Description:FIELD OF THE INVENTION
[0001] The present invention relates to the field of herbal composition. Particularly, the present invention pertains to a natural composition designed to improve sleep quality and reduce anxiety. More particularly, the present invention pertains to a synergistic blend of Bach flower remedies and other herbal extracts formulated into drops for sublingual administration. The composition provides a natural solution for stress management and sleep enhancement.
BACKGROUND
[0002] Now a days, stress is a prevalent issue impacting millions worldwide, significantly affecting individual’s physical, mental, and emotional health. According to recent studies, it is found that nearly one in four individuals in India reports stress-related complications. Also, chronic stress may affect the body's hormonal equilibrium, particularly influencing cortisol, the stress hormone. Elevated cortisol levels can suppress melatonin production, a hormone, that is essential for regulating sleep. This imbalance often leads to insomnia and poor sleep quality, creating a vicious cycle where stress exacerbates sleep disturbances, and inadequate rest intensifies stress. As a result, those affected may experience fatigue, impaired cognitive abilities, reduced productivity, and heightened anxiety.
[0003] Thus, to break such cycle of high stress and poor sleep quality, it is required to address both stress and its impact on sleep. Various natural remedies, such as mindfulness practices, relaxation techniques, and lifestyle modifications have proven effective in managing stress. These approaches not only help reduce cortisol levels but also promote better melatonin production, enabling improved sleep patterns. Additionally, lifestyle modifications, including regular exercise and stress-management therapy, can also improve the general well-being of the individual. Such approaches may address the very sources of stress and sleep disturbances, enabling the individual to regain control and prevent the widespread effects of chronic stress.
[0004] To overcome the above-mentioned problem, various conventional documents have proposed numerous therapies or formulation. However, such numerous therapies or formulation may have side effect, which may harm in long term usage. Also, such numerous therapies or formulation are ineffective at addressing both stress and sleep issues simultaneously.
[0005] For instance, according to conventional patent literature, US20160101139A1 discloses a homeopathic sleep aid composition designed for topical or oral administration. This composition includes a blend of snake venom and relaxation-inducing herbs such as Arnica Montana, Rhus toxicodendron, and Aesculus hippocastanum. The formulation aims to facilitate relaxation and aid sleep by acting as an antihistamine, GABA modulator, or through aromatherapeutic effects. Despite its comprehensive approach, this prior art primarily focuses on homeopathic principles and lacks a targeted mechanism to address the multifaceted nature of stress and sleep disturbances.
[0006] According to another conventional patent literature, CN107582449A illustrates a sleep mask containing plant extracts such as horse-chestnut seed extract, rattan green pepper extract, and Paraguay's grass extract. This formulation aims to nourish and repair the skin while promoting sleep through aromatherapy and anti-inflammatory properties. However, the application method, which involves a sleep mask, may not be convenient or suitable for all users, particularly those who prefer ingestible remedies for internal health benefits
[0007] According to yet another conventional patent literature, ITMI20000079A1 focuses on methods for preparing floral essences used in flower therapy. The remedies are designed to treat psychic discomfort and psychosomatic diseases using a range of botanical species, including Aesculus hippocastanum, Clematis vitalba, and Impatiens glandulifera. While this prior art recognizes the therapeutic potential of flower essences, it lacks a specific formulation tailored to address both stress and sleep issues concurrently in an efficient manner.
[0008] According to yet another conventional patent literatures, WO2016069580A1 and DE202013009980U1 describe cosmetic compounds combining therapeutic properties against fatigue and external agents. The prior art documents also mention use of Bach flower essences in cosmetic and nutritional supplements for promoting physical and emotional rebalancing. However, the primary focus of these inventions is on cosmetic applications and general well-being, rather than a targeted solution for stress-induced sleep disorders.
[0009] While these prior arts contribute significantly to their respective fields, but the existing technologies are devoid of providing formulation that can be combinedly effective for reducing stress and sleep disturbances.
[0010] Therefore, in order to avoid such problems, there is a need for a novel and advanced natural composition designed to improve sleep quality and reduce anxiety. The present disclosure is directed to overcome one or more limitations stated above, and any other limitation associated with the prior arts.
SUMMARY
[0011] One or more shortcomings of the prior art are overcome, and additional advantages are provided through the present disclosure. Additional features and advantages are realized through the techniques of the present disclosure. Other embodiments and aspects of the disclosure are described in detail herein and are considered a part of the claimed disclosure.
[0012] The present invention is directed to a composition, particularly a pharmaceutical composition, for reducing stress, improving sleep quality, and alleviating anxiety The composition comprises White Chestnut (scientifically known as Aesculus hippocastanum), Rock Rose (scientifically known as Helianthemum nummularium), Clematis (scientifically known as Clematis vitalba), Impatiens (scientifically known as Impatiens glandulifera), Cherry Plum (scientifically known as Prunus cerasifera), Star of Bethlehem (Ornithogalum umbellatum), and pharmaceutically acceptable excipients. These ingredients work synergistically in a sublingual drop format, facilitating rapid absorption for immediate relief and sustained benefits
[0013] According to an embodiment, the pharmaceutically acceptable excipients comprise a singular sweetening agent and a singular solvent. The singular sweetening agent belongs to a group consisting of Acesulfame Potassium, Alitame, Ammonium Glycyrrhizate, Aspartame, Cyclamate and Calcium Salt, Cyclamate, Fructose, Glycerin (Glycerol), Inulin, Isomalt, Lactitol, Maltitol, Maltose, Mannitol, Neohesperidin Dihydrochalcone, Neotame, Saccharin, Saccharin Sodium, Calcium Sorbitol, Steviol Glycosides, Sucralose. Further, the singular solvent belonging to a group consisting of Acetone, Alcohol, Benzyl Benzoate, Butyl Alcohol, Ethyl Acetate, Methyl Alcohol, Glycerine, Methylene Chloride, Methyl Isobutyl Ketone, Peanut Oil, Propylene Glycol, Stearoyl Polyoxtglycerides, Sorbitol Solution, Water Purified.
[0014] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
OBJECTIVE OF THE INVENTION
[0015] The primary object of the invention is to provide a novel formulation that effectively reduces stress and improves sleep quality by utilizing a unique combination of Bach flower remedies and herbal extracts. This formulation aims to address both the psychological and physiological aspects of stress-induced sleep disorders in a holistic manner.
[0016] Another object of the invention is to offer a sublingual drop format that ensures rapid absorption of the active ingredients, allowing for more immediate effects compared to traditional ingestible remedies. This method bypasses the digestive system, enabling the active components to enter the bloodstream directly and provide quicker relief from stress and sleep disturbances.
[0017] Another object of the invention is to utilize White Chestnut (Aesculus hippocastanum) to help calm racing thoughts and mental chatter, which are common barriers to falling asleep. By promoting mental tranquility, this ingredient aids in achieving a restful state conducive to sleep.
[0018] Another object of the invention is to incorporate Cherry Plum (Prunus cerasifera) for its natural melatonin content, which helps regulate sleep cycles and improve overall sleep quality. This ingredient is specifically selected to support the body's natural sleep-wake rhythm.
[0019] Another object of the invention is to use Rock Rose (Helianthemum nummularium) to reduce anxiety and promote a sense of calm. This ingredient targets the anxiety component of stress, making it easier for individuals to relax and fall asleep.
[0020] Another object of the invention is to include Impatiens (Impatiens glandulifera) to alleviate irritability and impatience, which are common symptoms of stress that can disrupt sleep. This ingredient helps create a more relaxed mental state, facilitating better sleep.
[0021] Another object of the invention is to employ Star of Bethlehem (Ornithogalum umbellatum) to provide relaxation and support emotional healing, particularly for individuals who have experienced trauma or shock. This ingredient contributes to overall emotional well-being, which is essential for improving sleep quality.
[0022] Another object of the invention is to incorporate Clematis (Clematis vitalba) for its recognized sleep-enhancing properties. This ingredient helps induce a state of relaxation and promotes deeper, more restorative sleep.
[0023] Another object of the invention is to provide a natural alternative to conventional sleep aids and stress-relief products, minimizing the potential for side effects commonly associated with synthetic medications. This formulation is designed to be safe and effective for regular use.
[0024] Another object of the invention is to address the multifaceted nature of stress and sleep disorders by combining ingredients that work synergistically to provide comprehensive relief. Each component is carefully selected to target specific aspects of stress and sleep disturbances, resulting in a formulation that is greater than the sum of its parts.
[0025] Another object of the invention is to improve overall quality of life for individuals suffering from chronic stress and sleep disorders by providing a reliable and effective remedy that enhances both mental and physical well-being. By reducing stress and improving sleep, this formulation can significantly impact daily functioning and long-term health.
DETAILED DESCRIPTION
[0026] In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.
[0027] While the disclosure is susceptible to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the drawings and will be described in detail below. It should be understood, however that it is not intended to limit the disclosure to the specific forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternative falling within the scope of the disclosure.
[0028] The terms “comprises”, “comprising”, “includes”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a setup, device, or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or device or method. In other words, one or more elements in a system or apparatus proceeded by “comprises… a” does not, without more constraints, preclude the existence of other elements or additional elements in the system or method.
[0029] Embodiment of the present invention relates to a natural composition designed to improve sleep quality and reduce anxiety.
[0030] According to an embodiment, the formulation comprises a unique blend of Bach flower remedies and herbal extracts designed to alleviate stress and improve sleep quality. Key components of the formulation include White Chestnut, scientifically known as Aesculus hippocastanum, for calming mental chatter, Cherry Plum scientifically known as Prunus cerasifera to regulate sleep cycles, Rock Rose scientifically known as Helianthemum nummularium for anxiety reduction, Impatiens scientifically known as Impatiens glandulifera to alleviate irritability, Star of Bethlehem scientifically known as Ornithogalum umbellatum for emotional healing, and Clematis scientifically known as Clematis vitalba to promote deeper sleep. These ingredients are carefully selected for their individual properties aimed at reducing stress, promoting relaxation, and enhancing sleep quality, thereby synergistically addressing the psychological and physiological aspects of anxiety and sleep disorders. These ingredients work synergistically in a sublingual drop format, facilitating rapid absorption for immediate relief and sustained benefits. Further, the formulation comprises pharmaceutically acceptable excipients.
[0031] According to an embodiment, the pharmaceutically acceptable excipients comprise a singular sweetening agent and a singular solvent. The singular sweetening agent belongs to a group consisting of Acesulfame Potassium, Alitame, Ammonium Glycyrrhizate, Aspartame, Cyclamate and Calcium Salt, Cyclamate, Fructose, Glycerin (Glycerol), Inulin, Isomalt, Lactitol, Maltitol, Maltose, Mannitol, Neohesperidin Dihydrochalcone, Neotame, Saccharin, Saccharin Sodium, Calcium Sorbitol, Steviol Glycosides, Sucralose. Further, the singular solvent belonging to a group consisting of Acetone, Alcohol, Benzyl Benzoate, Butyl Alcohol, Ethyl Acetate, Methyl Alcohol, Glycerine, Methylene Chloride, Methyl Isobutyl Ketone, Peanut Oil, Propylene Glycol, Stearoyl Polyoxtglycerides, Sorbitol Solution, Water Purified.
[0032] According to an embodiment, the herbal composition works involves its interaction with body's mechanisms. Upon administration, active ingredients bypass digestive system and are absorbed directly into the bloodstream under a tongue. The herbal composition enhances bioavailability, allowing the beneficial compounds to exert their effects quickly.
[0033] According to an embodiment, the herbal composition is prepared by combining precise proportions of each ingredient to ensure optimal efficacy and safety. Herbal extracts and Bach flower remedies are carefully selected and blended to maintain potency and consistency. The resulting formulation is prepared in a sublingual drop form, ensuring ease of use and rapid absorption. Quality control measures are implemented throughout the manufacturing process to guarantee purity, potency, and adherence to regulatory standards. The preparation method ensures that each dose delivers the intended therapeutic benefits effectively and reliably.
[0034] According to an embodiment, the formulation of the present invention discloses a synergistic blend with functional aspects of:
• White Chestnut: Contains active compounds that interact with neurotransmitter receptors, helping to alleviate persistent worrying and overactive mind;
• Rock Rose: Rich in flavonoids and terpenes that modulate neurotransmitter activity, reducing anxiety symptoms and promoting a sense of calm;
• Clematis: Enhances cognitive function by improving cerebral blood flow and regulating neurotransmitter levels, aiding in mental clarity and focus;
• Impatiens: Contains alkaloids that promote relaxation by modulating serotonin receptors, helping to reduce irritability and impatience;
• Cherry Plum: Supports emotional balance through its influence on GABA receptors, helping to manage feelings of fear and emotional instability; and
• Star of Bethlehem: Acts on the central nervous system to promote calmness and emotional healing, aiding in recovery from shock or trauma.
[0035] The formulation harnesses the synergistic effects of its key ingredients to enhance its overall efficacy in promoting relaxation and alleviating stress. Each component in the blend contributes unique pharmacological actions that, when combined, create a holistic approach to mental and emotional well-being.
[0036] According to an embodiment, the key components - White Chestnut, Rock Rose, Clematis, Impatiens, Cherry Plum, and Star of Bethlehem - each target different aspects of stress response mechanisms. White Chestnut calms persistent thoughts, Rock Rose reduces acute anxiety symptoms, Clematis improves focus, Impatiens soothes irritability, Cherry Plum stabilizes emotional turmoil, and Star of Bethlehem aids emotional recovery from shock or trauma.
[0037] According to an embodiment, ingredients of the formulation collectively influence neurotransmitter systems such as serotonin and GABA, crucial for mood regulation and stress management. By modulating these pathways, the formulation helps balance emotional responses and promotes a sense of calmness and relaxation. Clematis, known for its cognitive enhancing properties, synergizes with other ingredients to improve mental clarity and focus. This synergistic action supports overall cognitive function, enabling better stress management and emotional resilience. Cherry Plum and Impatiens work synergistically to alleviate emotional extremes—Cherry Plum helps manage irrational fears, while Impatiens addresses impatience and irritability. This dual action promotes emotional stability and resilience in challenging situations
[0038] Further, combination of Rock Rose and Star of Bethlehem contributes to natural relaxation and emotional healing. Rock Rose mitigates acute stress responses, while Star of Bethlehem supports emotional recovery and inner peace, enhancing the formulation’s overall calming effect.
[0039] According to an embodiment, the formulation supports natural relaxation and resilience, making it an effective solution for managing stress and promoting overall mental and emotional wellness. The ingredients of the formulation used in the formulation are obtained from their naturally occurring forms to ensure maximum efficacy and purity.
[0040] Among the ingredients, for example, White Chestnut, scientifically known as Aesculus hippocastanum, is sourced from mature chestnut trees. The seeds are collected, dried, and then processed into a fine powder or extract through a solvent extraction method. This process helps to concentrate the active compounds responsible for its calming effects on persistent, racing thoughts.
[0041] Among the ingredients, for example, Rock Rose, known as Helianthemum nummularium, is harvested during its peak flowering period. The flowers are carefully picked and subjected to the sunshine method, which involves floating the blooms on purified water in direct sunlight for several hours. This method energizes the water with the essence of Rock Rose, which is then mixed with alcohol to preserve its properties.
[0042] Among the ingredients, for example, Clematis, or Clematis vitalba, is also collected during its flowering stage. The flowers are processed using the sunshine method to extract their essence, which is later diluted and potentized according to homeopathic principles to enhance their focus-improving properties.
[0043] Among the ingredients, for example, Impatiens, or Impatiens glandulifera, is gathered from its natural habitat and processed using the sunshine method as well. The resulting essence is combined with alcohol and potentized to capture the flower's irritability-soothing characteristics.
[0044] Among the ingredients, for example, Cherry Plum, scientifically known as Prunus cerasifera, is obtained from its blooming trees. The blossoms are collected and subjected to the boiling method, where they are simmered in purified water. The resultant liquid is strained, cooled, and mixed with alcohol to produce a tincture, which is then potentized to stabilize emotional turmoil.
[0045] Among the ingredients, for example, Star of Bethlehem, or Ornithogalum umbellatum, is sourced from the star-like flowers of the plant. These flowers are boiled in purified water to release their essence, which is then preserved in alcohol and potentized. This process ensures that the emotional recovery and healing properties of Star of Bethlehem are fully harnessed. Each of these ingredients is processed to maintain their natural potency while ensuring they are in the optimal form for inclusion in the formulation. The combination of sunshine and boiling methods, followed by homeopathic potentization, ensures that the active compounds are effectively extracted and preserved, ready to deliver their intended therapeutic effects.
[0046] According to an embodiment, a process of manufacturing the formulation is meticulously carried out to ensure the highest quality and efficacy of the final product. The manufacturing process involves several stages, from the preparation of Bach flower remedies to the final formulation of the drops.
[0047] Firstly, the Bach flower remedies are prepared using two distinct methods – a sunshine method, and a boiling method.
[0048] The sunshine method comprises:
a) Taking a thin glass bowl and filled with purified water.
b) Picking up the blooms/blossoms of the plant and thereby immediately floating on a surface of the purified water, so as to cover the blooms/blossoms of the plant completely.
c) Then, the blooms/blossoms of the plant in the purified water is left in the bright sunshine for 3 to 7 hours or lesser time, if the blooms/blossoms begin to show signs of fading.
d) Removing carefully the blooms/ blossoms out, and the energized water is poured into bottles so as to half fill them.
e) Thereby, alcohol is added to fill the bottles.
f) Then, 2 drops this energized tincture is mixed with 30 milliliter (ml) of alcohol to prepare tinctures.
[0049] The boiling method comprises:
a) Boiling the Specimens with purified water for half an hour.
b) The fluid is strained off and poured into bottles up to half.
c) Then after cooling, alcohol is added to fill up the bottles.
d) Then, 2 drops of this energized tincture are mixed with 30 ml. of alcohol to prepare tinctures.
[0050] Secondly, preparation of the 30th potency remedies follow a systematic potentization process:
[0051] The initial tincture is diluted and subjected to potentization as per the Homoeopathic Pharmacopoeia of India. This process is repeated successively to achieve the 30th centesimal potency, where each step involves transferring the medicinal energy to fresh vehicle molecules, resulting in a higher potency remedy. For preparation of potentized homoeopathic preparations for use on patients, the first potency is prepared by mixing one part of the tincture with 99 parts of alcohol of 91% and giving 10 strokes as per the potentization technique of Homoeopathic Pharmacopoeia of India.
[0052] The successive homoeopathic potencies are prepared from first potency by mixing one part of first potency or the previous potency with 99 parts of alcohol of 91%, and subjecting to potentization techniques as mentioned in Homoeopathic Pharmacopoeia of India to have 30th Centesimal potency.
[0053] While preparing the homoeopathic potencies successively, as per the technique of the Homoeopathic Pharmacopoeia of India, the energy of the remedy is taken up by the Vehicle molecules and become the medicines of the next higher potency as per the system of Homoeopathy. While transferring energy to fresh Vehicle molecules during potentisation process, the said Vehicle molecules on receiving the medicinal energy of previous potency, is transformed into the homoeopathic medicine of the next higher potency
[0054] According to an embodiment, the final formulation of the six remedies of the 30th potency - White Chestnut (Aesculus hippocastanum), Rock Rose (Helianthemum nummularium), Clematis (Clematis vitalba), Impatiens (Impatiens glandulifera), Cherry Plum (Prunus cerasifera), and Star of Bethlehem (Ornithogalum umbellatum) - are combined, as follows:
i. White Chestnut (Aesculus hippocastanum) in an amount of 1% to 5% by volume;
ii. Rock Rose (Helianthemum nummularium) in an amount of 1% to 5% by volume;
iii. Clematis (Clematis vitalba) in an amount of 1% to 5% by volume;
iv. Impatiens (Impatiens glandulifera) in an amount of 1% to 5% by volume;
v. Cherry Plum (Prunus cerasifera) in an amount of 1% to 5% by volume;
vi. Star of Bethlehem (Ornithogalum umbellatum) in an amount of 1% to 5% by volume; and
vii. pharmaceutically acceptable excipients as balance amount.
[0055] The pharmaceutically acceptable excipients comprise:
i. A singular sweetening agent in an amount of 70% to 90% by volume belonging to a group consisting of: Acesulfame Potassium, Alitame, Ammonium Glycyrrhizate, Aspartame, Cyclamate And Calcium Salt,Cyclamate, Fructose, Glycerin (Glycerol), Inulin, Isomalt, Lactitol, Maltitol, Maltose, Mannitol, Neohesperidin Dihydrochalcone, Neotame, Saccharin, Saccharin Sodium, Calcium Sorbitol, Steviol Glycosides, Sucralose; and
ii. A singular solvent in an amount of 0.001% to 1% by volume belonging to a group consisting of: Acetone, Alcohol, Benzyl Benzoate, Butyl Alcohol, Ethyl Acetate, Methyl Alcohol, Glycerine, Methylene Chloride, Methyl Isobutyl Ketone, Peanut Oil, Propulene Glycol, Stearoyl Polyoxtglycerides, Sorbitol Solution, Water Purified, etc.
[0056] The ingredients of the composition are carefully sourced and processed to retain their natural potency and efficacy. The flowers used in the sunshine method are picked fresh and exposed to sunlight, which energizes the water with their healing properties. The boiling method ensures the full extraction of medicinal compounds from the plant specimens, which are then preserved in alcohol.
[0057] According to an exemplary embodiment, the herbal composition comprises:
i. White Chestnut (Aesculus hippocastanum) in an amount of 2.96% by volume;
ii. Rock Rose (Helianthemum nummularium) in an amount of 2.96% by volume;
iii. Clematis (Clematis vitalba) in an amount of 2.96% by volume;
iv. Impatiens (Impatiens glandulifera) in an amount of 2.96% by volume;
v. Cherry Plum (Prunus cerasifera) in an amount of 2.96% by volume;
vi. Star of Bethlehem (Ornithogalum umbellatum) in an amount of 2.96% by volume; and
vii. pharmaceutically acceptable excipients as balance amount.
[0058] The pharmaceutically acceptable excipients comprise:
i. the singular sweetening agent in an amount of 82.23 % by volume; and
ii. the singular solvent in an amount of 0.001% by volume.
[0059] According to another embodiment, for manufacturing the formulation, the six remedies of 30 potency namely, White chestnut, Rock Rose, Clematis, Impatiens, Cherry Plum, Star of Bethlehem are added in prescribed volume to prescribed volume of Glycerine and Purified water. Thereby, it is mixed well for 30 minutes.
[0060] The final product is manufactured under controlled conditions to maintain its therapeutic properties. The formulation is designed to provide relief from stress and improve sleep quality by leveraging the synergistic effects of the selected Bach flower remedies. Each ingredient in the formulation contributes uniquely to the overall effect, addressing various aspects of mental and emotional well-being.
[0061] The scrupulous process of preparation, potentization, and blending ensures that the final product is both effective and safe for use. The combination of these carefully selected ingredients works synergistically to enhance the body’s natural healing processes, providing a holistic remedy for stress and sleep-related issues.
Experimental and Clinical Trial Details:
[0062] An experiment has been conducted on individuals experiencing mild stress, aged between 18 to 45 years, to assess the compliance, clinical, vital parameter assessment, and tolerability of the probiotic formulation. The experiment is an open-label, single-arm, safety study, with each subject receiving 6-7 drops of Rescue Remedies and 6 (RR-6) daily after a meal and completing the study. RR-6 indicates number of ingredients. Ethics committee approval is obtained, and the experiment/ study is conducted in accordance with ICH-GCP guidelines. Written informed consent was obtained from all participants before enrollment. The trial was registered on the Clinical Trials Registry – India (CTRI) website, and enrollment began after registration. The study aimed to evaluate changes in Complete Blood Count (CBC), Liver Function Test (LFT), and Renal Function Test (RFT) parameters, as well as Perceived Stress Levels (PSS Score) and Insomnia Severity Index (ISI) using standardized scales. Adverse events were also monitored throughout the study period.
[0063] A study protocol and related documents underwent review and approval by the Ethics Committee (EC) before subject recruitment. Subjects are enrolled only after EC approval, and there are no protocol changes post-approval. The study is initiated after obtaining written approval from the Institutional Ethics Committee (IEC) of Lokmanya Medical Research Centre, Chinchwad, Pune, Maharashtra, India (ECR/175/Inst/MH/2013/RR-19), and conducted in accordance with the approved protocol and ICH-Good Clinical Practices (GCP) guidelines.
[0064] The study adhered strictly to ICH-GCP guidelines. Throughout the trial, the rights, safety, and well-being of participants are paramount. Investigational products are prepared in compliance with Good Manufacturing Practices (GMP) as applicable in India.
[0065] Voluntary written informed consent is obtained from subjects prior to their participation in the study. The informed consent process included a detailed explanation of the study objectives, design, risks, and benefits. For illiterate subjects, an impartial witness read and explained the Informed Consent Form (ICF) in the language understood by the subject. Thumb impressions of illiterate subjects and signatures of impartial witnesses are obtained on the ICF. Subject identities are kept confidential, and study data is coded. The results of the study may be published in peer-reviewed scientific journals with investigators' consent, without disclosing subject identities.
[0066] After ethics committee approval, the trial is registered on the CTRI website with registration number CTRI/2024/03/064117 (Registered on: 14/03/2024). Subject enrollment commenced only after CTRI registration.
[0067] The study's primary objectives are to evaluate the compliance, clinical parameters, vital signs, and tolerability of the investigational product from baseline to the end of the study. Additionally, changes in CBC, LFT, and RFT parameters are assessed at screening and on day 30, along with the monitoring of adverse events throughout the study period. Secondary objectives included the Assessment of changes in perceived stress by perceived stress scale (PSS) score at screening and day 30, and the Assessment of changes in insomnia severity index (ISI) at screening and day 30. The following inclusion criteria and exclusion criteria are followed for performing the experiment.
Inclusion Criteria:
[0068] Male and female individuals aged between 18 to 45 years (both inclusive) are included in the study. Participants are required to have scored between 7 to 26 on the Perceived Stress Scale (PSS) that are included in the study. Participants who are suffering from symptoms of insomnia disorder as per the investigator's discretion are included in the study. Participants who are not consuming sedatives, anti-depressants /anti-anxiety/ mood enhancing/ recreational drugs intake for at least one year at the start of the screening visit are included in the study. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. Subjects are willing to follow up.
Exclusion Criteria:
[0069] Women with childbearing potential and not taking adequate contraceptive precautions were excluded from the study. Pregnant or lactating women are excluded from the study. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking are excluded from the study. Participants with neurological conditions are excluded from the study. Participants with comorbidities are excluded from the study. The subjects taking any medicine or dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress are excluded from the study. Any other clinical condition in the judgment of the investigator finds the study participation unsuitable for the participant.
Results:
[0070] All thirty participants (19 males and 11 females) successfully completed the study. The average age of the subjects is 34.33 ± 9.87 years. Male participants have an average weight of 66.02 kg, a height of 166.51 cm, and a BMI of 23.98 kg/m². Female participants have an average weight of 62.45 kg, a height of 155.07 cm, and a BMI of 25.96 kg/m². These demographic details are summarized in Table 1 below:
Parameters Male (Mean ± SD) Male (n=19) Female (Mean ± SD) Female (n=11) P Value
Average Age (Years) 34.26 ± 10.39 19 34.45 ± 9.38 11 0.96
Height (cm) 166.51 ± 11.42 19 155.07 ± 10.12 11 0.011*
Weight (kg) 66.02 ± 9.56 19 62.45 ± 11.60 11 0.37
BMI (kg/m2) 23.98 ± 4.16 19 25.96 ± 4.19 11 0.22
Table 1
[0071] The analysis of the hematological and biochemical parameters showed some statistically significant changes between the screening and day 30-time points. Specifically, there are significant decreases in red blood cell count (p=0.033) and increases in hematocrit (PCV) (p=0.003), mean corpuscular volume (MCV) (p=0.019), and mean corpuscular hemoglobin (MCH) (p=0.014). Additionally, there is a significant increase in platelet count (p<0.001). However, these changes, while statistically significant, are relatively small in magnitude and remained within the respective reference ranges, suggesting they are not clinically meaningful. All other blood parameters, including liver and kidney function tests, are stable over the 30-day evaluation period. Such hematological parameters are provided in Table 2 below. In Table 2, data is represented as Mean ± S.D. Analysis is done using the dependent student t-test (within the group) and Wilcoxon signed rank test (within the group). Significant at p< 0.05.
Hematological parameters:
Parameters Screening Day 30 P Value Reference Range
White Blood Cell Count (WBC) 8190.00 ± 2210.53 8053.33 ± 1369.05 0.627 (4000 - 11000 cell/cu.mm)
Red Blood Cell Count (RBC) 4.86 ± 0.68 4.55 ± 0.53 0.033* (4.7 - 6.0 mil/cu.mm)
Hemoglobin (Hb) 12.83 ± 1.82 12.97 ± 1.36 0.323 (Female: 11.6 - 15 gm/dL & Male: 13.2-16.6 gm/dL)
Haematocrit (PCV) 38.40 ± 5.81 42.79 ± 5.29 0.003* (42 - 52 %)
Mean Corpuscular Volume (MCV) 79.06 ± 9.48 83.47 ± 9.48 0.019* (78 - 100 fL)
Mean Corpuscular Haemoglobin (MCH) 26.00 ± 3.93 28.53 ± 4.62 0.014* (27 - 31 pg)
Mean Corpuscular Haemoglobin Concentration (MCHC) 32.75 ± 1.59 32.75 ± 0.99 0.98 (32-36 gm/dL)
Platelet Count 300.33 ± 80.93 306.83 ± 89.85 <0.001* (150 - 450 10^3/ul)
Neutrophils 64.13 ± 6.05 62.30 ± 5.44 0.083 (40 - 75 %)
Lymphocytes 28.73 ± 5.00 28.93 ± 5.31 0.88 (20 - 40 %)
Monocytes 3.77 ± 1.59 3.47 ± 0.97 0.332 (2-10 %)
Eosinophils 3.13 ± 0.82 3.10 ± 0.76 0.881 (1-6 %)
Basophils 0.00 ± 0.00 0.00 ± 0.00 1 (0-1 %)
Table 2
[0072] Kidney function is provided in Table 3 below. Data is represented as Mean ± S.D. Analysis was done using the dependent student t-test (within the group) and Wilcoxon signed rank test (within the group). Significant at p< 0.05.
Kidney function:
Parameters Screening Day 30 P Value Reference Range
Urea 19.27 ± 4.01 18.65 ± 3.13 0.491 (10-50 mg/dL)
Creatinine 0.79 ± 0.17 0.73 ± 0.29 0.189 (Female:0.6-1.4 & Male:0.7-1.4 mg/dL)
Uric Acid 3.93 ± 1.13 4.01 ± 0.96 0.354 (3.0 to 7.2 mg/dL)
Table 3
[0073] Liver function is provided in Table 4 below. Data is represented as Mean ± S.D. Analysis was done using the dependent student t-test (within the group) and Wilcoxon signed rank test (within the group). Significant at p< 0.05.
Liver function:
Parameters Screening Day 30 P Value Reference Range
Total Protein 7.24 ± 0.53 7.17 ± 0.68 0.649 (6.0 - 8.3 g/dL)
Albumin 4.35 ± 0.33 4.32 ± 0.36 0.76 (3.2 - 5.5 g/dL)
Globulin 2.89 ± 0.34 2.85 ± 0.48 0.676 (1.8 - 3.6 g/dL)
A/G Ratio 1.52 ± 0.19 1.52 ± 0.26 0.586 (1.2 - 2.2)
Total Bilirubin 0.57 ± 0.35 0.60 ± 0.29 0.727 (0.1-1.2 mg/dL)
Direct Bilirubin 0.25± 0.16 0.27 ± 0.12 0.404 (0-0.4 mg/dL)
Indirect Bilirubin 0.32 ± 0.23 0.34 ± 0.22 0.493 (0.1-0.8 mg/dL)
Aspartate Transaminase (AST) 26.00 ± 10.55 26.57 ± 8.62 0.582 (49 U/ L)
Alanine Transaminase (ALT) 22.21 ± 7.01 23.90 ± 7.63 0.069 (49 U/dL)
Alkaline Phosphatase 88.38 ± 24.43 90.28 ± 23.37 0.553 (80 - 306 U/ L)
Table 4
[0074] There is a statistically significant increase in heart rate from the screening to the day 30 time point. However, the magnitude of this change is relatively small and remained within the normal physiological range. There are no other statistically significant differences observed in systolic blood pressure, diastolic blood pressure, body temperature, or respiratory rate between the two study visits is provided in Table 5 below. These findings indicate the study intervention had a minimal impact on the participants' vital sign parameters over the 30-day evaluation period. Data is represented as Mean ± S.D. Analysis was done using the dependent student t-test (within the group) and Wilcoxon signed rank test (within the group). Significant at p< 0.05.
Parameters Screening (Mean ± SD) Day 30 (Mean ± SD) P Value
Systolic Blood Pressure (mmHg) 123.40 ± 5.77 122.30 ± 5.21 0.412
Diastolic Blood Pressure (mmHg) 79.53 ± 7.53 77.20 ± 3.59 0.094
Heart Rate (bpm) 72.40 ± 3.64 74.90 ± 4.32 0.017*
Body Temperature (°F) 97.22 ± 0.68 97.11 ± 0.65 0.535
Respiratory Rate (breaths per minute) 20.10 ± 1.37 19.53 ± 1.11 0.073
Table 5
[0075] The adverse events observed during the study are presented in Table 6 below. Out of the 30 participants, a total of 4 subjects (13.33%) experienced at least one adverse event. The most commonly reported adverse events are headache, nausea, fever, and body pain. For each adverse event, the number of subjects affected and the corresponding rescue medication used are shown. AE’s observed are not related to investigational product.
Adverse Events No (N=30) Rescue Medication
Nausea 1 Pan-D
Headache 1 Nicipplus
Fever 1 Dolo 650
Body pain 1 Acemiz MR
Total No. of Events 4
Total No. of subjects (%) 4 (13.33%)
Table 6
[0076] The Perceived Stress Scale (PSS) is a ten-question questionnaire with responses from 0 to 4, measuring an individual's stress perception. The total score is the sum of all responses, indicating the perceived stress level. Scores: 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress). The assessment of perceived stress using the PSS demonstrated a statistically significant decrease from the screening visit to the end of the study on day 30 by 36.74%. Data is presented in Table 7 below. The observed change in PSS score was statistically highly significant, suggesting a clinically meaningful improvement in the participant's subjective experience of stress. Data is represented as Mean ± S.D. Analysis was done using the Wilcoxon signed rank test (within the group). Significant at p< 0.05.
Parameters Screening Day 30 P Value
PSS SCORE 24.93 ± 1.39 15.77 ± 3.16 <0.001*
Table 7
[0077] The Insomnia Severity Index (ISI) is a 7-item questionnaire that assesses the severity of insomnia, where each question was scored as follows: None (0), Mild (1), Moderate (2), Severe (3), Very Severe (4), with total scores ranging from 0 to 28 and higher scores indicating more severe insomnia.
[0078] The analysis of the ISI scores revealed a statistically significant decrease of 43.67% over the course of the 30-day study period. These findings indicate the study intervention have a substantial positive impact on reducing insomnia symptoms in the participants as demonstrated in Table 8 below. Data is represented as Mean ± S.D. Analysis was done using the Wilcoxon signed rank test (within the group). Significant at p< 0.05.
Parameters Screening Day 30 P Value
Insomnia Severity 20.47 ± 2.03 11.53 ± 1.63 <0.001*
Table 8
[0079] Finally, the language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by any claims that issue on an application based here on. Accordingly, the disclosure of the embodiments of the invention is intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims.
[0080] With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.
[0081] While various aspects and embodiments have been disclosed herein, other aspects and embodiment will be apparent to those skilled in the art.
, Claims:We Claim:
1. A composition for reducing stress, improving sleep quality, and alleviating anxiety , the composition comprising:
White Chestnut (Aesculus hippocastanum);
Rock Rose (Helianthemum nummularium);
Clematis (Clematis vitalba);
Impatiens (Impatiens glandulifera);
Cherry Plum (Prunus cerasifera);
Star of Bethlehem (Ornithogalum umbellatum); and
pharmaceutically acceptable excipients.
2. The composition as claimed in claim 1, wherein the pharmaceutically acceptable excipients comprise:
a singular sweetening agent belonging to a group consisting of Acesulfame Potassium, Alitame, Ammonium Glycyrrhizate, Aspartame, Cyclamate and Calcium Salt, Cyclamate, Fructose, Glycerin (Glycerol), Inulin, Isomalt, Lactitol, Maltitol, Maltose, Mannitol, Neohesperidin Dihydrochalcone, Neotame, Saccharin, Saccharin Sodium, Calcium Sorbitol, Steviol Glycosides, Sucralose; and
a singular solvent belonging to a group consisting of Acetone, Alcohol, Benzyl Benzoate, Butyl Alcohol, Ethyl Acetate, Methyl Alcohol, Glycerine, Methylene Chloride, Methyl Isobutyl Ketone, Peanut Oil, Propylene Glycol, Stearoyl Polyoxtglycerides, Sorbitol Solution, Water Purified.
3. The composition as claimed in claim 1, wherein the formulation comprises:
the White Chestnut in an amount of 1% to 5% by volume;
the Rock Rose in an amount of 1% to 5% by volume;
the Clematis in an amount of 1% to 5% by volume;
the Impatiens in an amount of 1% to 5% by volume;
the Cherry Plum in an amount of 1% to 5% by volume;
the Star of Bethlehem in an amount of 1% to 5% by volume; and
the pharmaceutically acceptable excipients as balance amount.
4. The composition as claimed in claim 3, wherein the pharmaceutically acceptable excipients comprise the singular sweetening agent in an amount of 70% - 90% by volume and the singular solvent in an amount of 0.001% - 1% by volume.
5. The composition as claimed in claim 1, wherein the White Chestnut is sourced from mature chestnut trees, wherein seeds are collected, dried, and then processed into a fine powder or extract through a solvent extraction technique.
6. The composition as claimed in claim 1, wherein Rock Rose flowers are carefully picked and flower blooms are floated on purified water in direct sunlight for several hours in order to energize the water with the essence of Rock Rose, which is further mixed with alcohol to preserve properties of the Rock Rose.
7. The composition as claimed in claim 1, wherein the Clematis is also collected during flowering stage and processed to extract their essence, which is later diluted and potentized to enhance their focus-improving properties.
8. The composition as claimed in claim 1, wherein the Impatiens are gathered from natural habitat and processed to extract essence that is combined with alcohol and potentized to capture the flower's irritability-soothing characteristics.
9. The composition as claimed in claim 1, wherein the Cherry Plum is obtained from blooming trees, wherein blossoms are collected, simmered in purified water, and resultant liquid is strained, cooled, and mixed with alcohol to produce a tincture, which is then potentized.
10. The composition as claimed in claim 1, wherein Star of Bethlehem is sourced from the star-like flowers of the plant and the flowers are boiled in purified water to release their essence, which is then preserved in alcohol and potentized.