Description:FIELD OF THE INVENTION
[0001] The present invention relates to the field of nutraceutical formulations. More particularly, the present invention pertains to a nutraceutical formulation for improving mental focus and managing stress with safety and efficacy evaluation.
BACKGROUND
[0002] Nowadays, many people struggle with mental focus and stress management due to a combination of lifestyle, environmental, and psychological factors. The rapid pace of modern life and constant exposure to digital devices create an environment of overstimulation, making it hard for individuals to concentrate on single tasks. Social media and news overload amplify stress by constantly exposing people to negative events or unrealistic standards of success. Additionally, high expectations in both professional and personal lives lead to chronic stress, with limited time for relaxation or personal pursuits. Lack of physical activity, poor sleep, and unbalanced diets also impact brain health, while diminishing opportunities for meaningful social interactions can lead to feelings of isolation and anxiety. Together, these factors create a cycle of distraction, fatigue, and stress, making it difficult for people to focus and effectively manage stress in their lives.
[0003] Various prior arts have explored different compositions and applications focused on formulation aimed at reducing stress and enhancing cognition to relieve stress and boost focus and memory. However, none of the prior arts discloses any formulation for improving mental focus and managing stress without added sugar or artificial ingredients.
[0004] Particularly, in a patent literature, CN103520619A describes a Chinese medicine preparation using Rhizoma Alpiniae Officinarum and Fructus Crataegi to guide qi downwards, calm adverse-rising energy, remove qi stagnation, and relieve pain. This formulation is aimed primarily at gastrointestinal tract issues and post-operative recovery, not specifically at stress reduction or cognitive enhancement.
[0005] In another patent literature, US20180035705A1 discloses compositions providing extended energy and methods of use. The compositions use a minimal amount of caffeine along with astragaloside, ginsenoside, and stilbenoid compounds. While this formulation focuses on providing sustained energy, it does not directly address cognitive enhancement or stress management, and it relies on caffeine, which the present invention has been intended to avoid.
[0006] In yet another non-patent literature, AU2020343016A1 discloses nutritional supplements and methods of nutritional supplementation affecting mood and focus in children. The nutritional supplements comprise saffron stigma extract, holy basil leaf extract, rosemary leaf extract, oregano leaf extract, clove flower extract, and prebiotic fiber aimed at improving mood and focus in children. While it targets cognitive function and mood, the ingredients and focus population differ significantly from the present invention.
[0007] In yet another non-patent literature, US20200197474A1 discloses a composition for treatment and management of dementia and cognitive dysfunction and method of preparation thereof. The composition includes Bacopa monnieri, Convolvulus pluricaulis, Mucuna pruriens, Nardostachys jatamansi, Rauwolfia serpentina, Withania somnifera, Acorus calamus, Sida cordifolia, Emblica officinalis, Shilajit, Rasa sindura, and bhasmas. The composition aimed at treating dementia and cognitive impairments associated with neuro-degenerative disorders.
[0008] In yet another non-patent literature, US20210213093A1 discloses compositions and methods for activating cellular signaling pathways. The compositions contain milk thistle, ashwagandha, green tea, bacopa monnieri, and turmeric to boost stress response and promote health. Composition of the US20210213093A1 and intended usage for stimulating cellular signaling pathways distinguish it from the present invention's focus on cognitive function and stress management.
[0009] In yet another non-patent literature, US10265343B2 relates to kits and methods for nutrition supplementation. The method particularly relates to co-administration of various vitamins and mineral compositions to supplement the nutritional needs of individuals within physiologically stressful states. However, the prior art specifically fails to improve mental focus and manage stress of human being.
[0010] In yet another non-patent literature, WO2023183759A2 describes adaptogen formulations and methods of use. The nutritional compositions comprising adaptogens like Withania somnifera, Schisandra chinensis, Rhodiola rosea, Panax quinquefolius, and Panax ginseng to improve focus, energy, and stress conditions. This formulation aligns closely with the current invention in its use of adaptogens for cognitive and stress-related benefits but differs in its specific combination of ingredients.
[0011] 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 enhancing cognitive function and reducing stress.
[0012] Therefore, in order to avoid such problems, there is a need for a novel and advanced nutraceutical formulation that addresses common mental stress and improve mental focus through a unique blend of ingredients. The present disclosure is directed to overcome one or more limitations stated above, and any other limitation associated with the prior arts.
SUMMARY
[0013] 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.
[0014] The present invention is directed to a nutraceutical formulation for improving mental focus and reducing stress. The nutraceutical formulation comprises a blend of EnXtra (Alpinia galanga) extract, Saffron (Crocus sativus L.) extract, Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin), Ashwagandha Root (Withania somnifera) extract, Blueberry (Vaccinium corymbosum) extract, and pharmaceutically acceptable excipients.
[0015] According to an embodiment, the pharmaceutically acceptable excipients further comprise a diluent, a stabilizer, an anti-caking agent, and a capsule shell. The diluent comprises a component selected from a group of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, or Sodium starch glycolate. The stabilizer comprises a component selected from a group of Povidone (PVP), Polyvinyl alcohol (PVA), Polyethylene glycol (PEG), Hypromellose (HPMC), Hydroxypropyl cellulose (HPC), Hydroxyethyl cellulose (HEC), Carboxymethylcellulose sodium (NaCMC), Docusate sodium (SD), Sodium lauryl sulfate (SLS), Polyethylene imine (PEI), D-α- tocopheryl polyethylene glycol succinate (TPGS), Polyethylene oxide (PEO), CrosPovidone, or Polypropylene oxide (PPO). The anti-caking agent comprises a component selected from a group consisting of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, or Yellow prussiate of soda. The capsule shell comprises a component selected from a group consisting of Mannitol, Hydroxypropyl methylcellulose, Microcrystalline cellulose, Lactose, Pregelatinized starch 1500, or Corn starch.
[0016] 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
[0017] The primary objective of a nutraceutical formulation is to provide a natural, non-habit-forming solution to improve cognitive function and manage stress. It addresses the challenges of focus and concentration in a high-stress, fast-paced environment, offering a safe alternative to caffeine-based supplements for sustained energy and mental clarity without side effects.
[0018] The nutraceutical formulation is carefully designed to combine powerful herbal ingredients that enhance cognition and relieve stress. The formulation aims to improve mental performance, memory, and energy while managing cortisol levels to reduce stress. The use of natural ingredients ensures benefits like improved focus and reduced stress without the risk of dependency or side effects often linked to synthetic additives.
[0019] A key feature of the formulation is a herbal blend that enhances focus and concentration by interacting with neurotransmitters like dopamine and acetylcholinesterase, which boosts alertness and mental clarity. Supported by clinical studies, this blend provides sustained energy and improved cognitive function, making it ideal for individuals aiming to maintain peak mental performance throughout the day.
[0020] Additionally, the formulation includes Ashwagandha, an adaptogen known for balancing cortisol levels and reducing stress. Proven effective in managing stress, Ashwagandha promotes calm and well-being, supporting both mental clarity and focus while helping individuals better handle stress.
[0021] Moreover, Blueberry Extract is included in the formulation for its memory-boosting and cognitive-enhancing properties. Rich in antioxidants, the formulation promotes brain blood flow, improving focus and alertness. The natural ingredient aligns with the formulation’s goal of supporting brain health and cognitive performance.
[0022] Also, Saffron Extract is added to the formulation for its stress-relieving and antioxidant benefits, helping to balance cortisol levels and enhance mood. Such inclusion supports a holistic approach to stress management, promoting a balanced and focused mind.
DETAILED DESCRIPTION
[0023] 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.
[0024] 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.
[0025] 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.
[0026] The present disclosure relates to a nutraceutical formulation for improving mental focus and reducing stress.
[0027] The formulation comprises a herbal mix that increases attention and concentration, with Ashwagandha regulating cortisol levels, Blueberry Extract increasing memory and cognitive function, and Saffron Extract reducing stress. The nutraceutical composition boosts energy and focus without caffeine, improves memory, regulates cortisol levels, and decreases stress. The nutraceutical formulation contains no sugar or artificial additives.
[0028] According to an embodiment, the nutraceutical formulation comprises a blend of EnXtra (Alpinia galanga) extract, Saffron (Crocus sativus L.) extract, Vitamin B3 (Nicotinamide), Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (Cyanocobalamin), Ashwagandha Root (Withania somnifera) extract, Blueberry (Vaccinium corymbosum) extract, and pharmaceutically acceptable excipients.
[0029] The EnXtra (Alpinia galanga) extract is present in the formulation in an amount ranging from 15.00% to 25.00% by weight per capsule. The weight relates to total weight of the composition and pharmaceutically acceptable excipients. The Alpinia galanga has a unique ability to interact with neurotransmitters like dopamine and acetylcholinesterase. Such unique ability plays essential roles in enhancing alertness and focus. The natural extract supports cognitive function without relying on stimulants, providing a caffeine-free alternative for individuals who want to boost mental performance without experiencing the jitteriness or energy. By modulating dopamine and acetylcholinesterase activity, Alpinia galanga promotes sustained mental clarity and focus, helping users maintain alertness in a smooth and balanced way. This makes it an ideal ingredient for those seeking cognitive support with minimal risk of side effects, aligning well with the formulation's overall goal of stress-free cognitive enhancement.
[0030] The Saffron (Crocus sativus L.) extract is present in the formulation in an amount ranging from 1.50% to 2.50% by weight per capsule. The Saffron extract is obtained from vivid red stigmas of Crocus sativus flower. This extract is highly valued for its natural stress-relieving and antioxidant properties, making it a powerful addition to the formulation. Known to aid in balancing cortisol levels - a hormone associated with stress - Saffron Extract helps the body respond to stress in a healthier way, reducing anxiety and promoting a sense of calm and well-being. Additionally, its antioxidant content protects the brain from oxidative stress, which can otherwise impair cognitive function over time. By enhancing overall mood and emotional stability, Saffron Extract supports a more balanced mental state, aligning with the formulation's goal of holistic stress management and cognitive support.
[0031] The Ashwagandha Root (Withania somnifera) extract is present in an amount ranging from 12.00% to 18.00% by weight per capsule. The Withania somnifera is a revered adaptogenic herb. As an adaptogen, Ashwagandha helps the body adapt to and manage stress more effectively by reducing cortisol levels, the hormone responsible for body's stress response. By lowering cortisol, the extract promotes a sense of calm, helps alleviate anxiety, and enhances overall mental well-being. This full-spectrum extract captures the diverse beneficial compounds of the plant, ensuring that users receive the full range of its therapeutic effects. Additionally, the extract is processed using 'Green Chemistry' techniques, which emphasize environmentally friendly, sustainable methods to produce the extract without the use of harmful chemicals or additives. A “full-spectrum” extract is an extract which maintains the balance of the various constituents as in the original herb, without over-representing any one constituent. The “full-spectrum” extract is produced using a unique proprietary extraction process, based on the “Green Chemistry” principles, without using alcohol or any other chemical solvent. With “Green Chemistry” processing, it is possible to holistically extract all root essence while preserving its natural healing potency. This proved to be immensely successful. This ensures the purity and safety of the Ashwagandha, making it an ideal ingredient for those seeking natural, stress-reducing support in their daily routine. In a non-limiting example, KSM-66 is the best ashwagandha extract available in market today in a sense that it is the highest concentration full-spectrum extract available today.
[0032] The Blueberry (Vaccinium corymbosum) extract in an amount ranging from 30.00% to 35.00% by weight per capsule. Blueberry Extract is a potent source of antioxidants and essential nutrients known to enhance cognitive function. The Blueberry Extract is rich in anthocyanins, the natural compounds responsible for the deep blue color of blueberries, which have been shown to promote improved blood flow to the brain. This increased circulation supports better oxygen and nutrient delivery to brain cells, which in turn aids in boosting memory, focus, and overall cognitive performance. Additionally, the high antioxidant content of the extract helps protect the brain from oxidative stress, which can contribute to cognitive decline over time. By incorporating Blueberry Extract, the formulation enhances mental clarity and supports long-term brain health, making it an ideal component for individuals looking to improve their cognitive abilities and mental sharpness.
[0033] In addition to that, the formulation also includes essential vitamins B3, B6, and B12, such as B4, B6, and that play crucial roles in supporting overall brain health and function. Vitamin B3 (Nicotinamide) is present in an amount ranging from 0.75% to 1.50% by weight per capsule. Vitamin B3 is vital for energy production, as it helps convert food into usable energy in the body. It also contributes to cognitive function by supporting the production of neurotransmitters and promoting brain cell metabolism.
[0034] Vitamin B6 (Pyridoxine Hydrochloride) is present in an amount ranging from 0.10% to 0.25% by weight per capsule. Vitamin B6 is an integral to the synthesis of neurotransmitters such as serotonin, dopamine, etc., which are crucial for mood regulation, focus, and brain development.
[0035] Lastly, Vitamin B-12, is present in trace amounts, essential for maintaining the health of nerve cells and red blood cells. It plays a significant role in the synthesis of DNA and the formation of myelin, the protective sheath around nerve fibers, thereby supporting healthy brain function and preventing neurological damage. Together, these B vitamins work synergistically to ensure optimal brain health, cognitive performance, and overall well-being.
[0036] According to an embodiment, the pharmaceutical excipients are substances used in pharmaceutical dosage forms that are not active drugs. While these excipients are generally considered inert and do not play a direct therapeutic role, they assist in the manufacturing process and help create an effective product. In the current formulation, the pharmaceutical excipients belong to various functional categories, including diluents, bulking agents, stabilizers, sweeteners, emulsifiers, antioxidants, acidity regulators, and flavor enhancers. These excipients work together to improve the taste, stability, and overall effectiveness of the formulation.
[0037] According to an embodiment, the pharmaceutically acceptable excipients comprise a diluent, a stabilizer, an anti-caking agent, and a capsule shell.
[0038] The diluent is present in an amount ranging from 5-10% by weight per capsule. The diluent comprises a component selected from a group of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, or Sodium starch glycolate. The diluent is an inactive substance or excipient added to a pharmaceutical formulation to increase its volume or bulk, making it easier to handle, manufacture, and administer.
[0039] Further, the stabilizer is present in an amount ranging from 1-5% by weight per capsule. The stabilizer comprises a component selected from a group of Povidone (PVP), Polyvinyl alcohol (PVA), Polyethylene glycol (PEG), Hypromellose (HPMC), Hydroxypropyl cellulose (HPC), Hydroxyethyl cellulose (HEC), Carboxymethylcellulose sodium (NaCMC), Docusate sodium (SD), Sodium lauryl sulfate (SLS), Polyethylene imine (PEI), D-α- tocopheryl polyethylene glycol succinate (TPGS), Polyethylene oxide (PEO), CrosPovidone, or Polypropylene oxide (PPO). The stabilizer is an excipient used in pharmaceutical formulations to help maintain the stability of the active ingredients and prevent degradation over time.
[0040] Furthermore, the anti-caking agent is present in an amount ranging from 0.01-5% by weight per capsule. The anti-caking agent comprises a component selected from a group consisting of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, or Yellow prussiate of soda. The anti-caking agent is a substance added to powders or granular products to prevent them from clumping or forming lumps.
[0041] Moreover, the capsule shell is present in an amount ranging from 10-20% by weight per capsule. The capsule shell comprises a component selected from a group consisting of Mannitol, Hydroxypropyl methylcellulose, Microcrystalline cellulose, Lactose, Pregelatinized starch 1500, or Corn starch. The capsule shell is the outer casing of a capsule, which is a type of dosage form used to deliver medication or supplements.
[0042] According to another embodiment, the pharmaceutically acceptable excipients belong to a group consisting of diluent, bulking agent, stabilizer, sweetener, emulsifie, anti-oxidant, acidity regulator, flavour enhancer different functional groups enhancing the taste, stability and effectiveness of the formulation as excipients.
[0043] This nutraceutical formulation is designed for oral administration and can be adapted into various forms such as tablets, capsules, powder, liquid, granules, syrups, and suspensions. The combination of these ingredients results in a synergistic effect that not only enhances cognitive function but also significantly reduces stress levels, leading to an overall improvement in mental and emotional well-being.
[0044] According to another embodiment, the pharmaceutical acceptable excipients used in the present invention are:
the diluent in an amount of 9% by weight per capsule;
the stabilizer in an amount of 3% by weight per capsule;
the anti-caking agent in an amount of 1% by weight per capsule; and
the capsule shell in an amount of 16% by weight per capsule.
[0045] In a non-limiting example, the nutraceutical formulation of 780 mg weight comprises:
EnXtra Extract (Alpinia galanga) in an amount of 100 mg to 200 mg;
Saffron Extract (Crocus sativus L.) in an amount of 10 mg to 20 mg;
Vitamin B3 (Nicotinamide) in an amount of 5 mg to 10 mg;
Vitamin B6 (Pyridoxine Hydrochloride) in an amount of 0.1 mg to 1 mg;
Vitamin B12 (Cyanocobalamin) in an amount of 1.0 mcg to 2.0 mcg;
Ashwagandha Root Extract (Withania somnifera) in an amount of 100 mg to 200 mg; and
Blueberry Extract (Vaccinium corymbosum) in an amount of 200 mg to 400 mg.
Experimental and Clinical Trial Details:
[0046] An experiment has been conducted on individuals experiencing mild to moderate stress, aged between 18 to 60 years, to assess the compliance, clinical, vital parameter assessment, and tolerability of the formulation. The experiment trail is an open-label, single-arm, safety study, with each subject receiving the formulation daily after a meal for 30 days. Ethics committee approval was obtained, and the study was conducted in accordance with ICH-GCP guidelines. Written informed consent was obtained from all participants before enrollment. The trial was registered on the CTRI website, and enrollment began after registration. The study aimed to evaluate changes in CBC, LFT, and RFT parameters, as well as clinical, vital parameters, tolerability, alertness, memory, perceived energy and perceived stress levels using standardized scales. Adverse events were also monitored throughout the study period.
[0047] A study protocol and associated documents were reviewed and approved by the ethics committee (EC) prior to the recruitment of subjects. Enrollment of participants occurred only after receiving EC approval, and no changes were made to the protocol after approval. The study commenced following 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 was conducted in full compliance with the approved protocol and ICH-Good Clinical Practices (GCP) guidelines.
[0048] The study adhered strictly to ICH-GCP guidelines, ensuring the rights, safety, and well-being of participants were of utmost importance throughout the trial. Investigational products were prepared in accordance with Good Manufacturing Practices (GMP) standards applicable in India.
[0049] Before participation, written informed consent was voluntarily obtained from all subjects. The informed consent process included a thorough explanation of the study's objectives, design, risks, and benefits. For illiterate participants, an impartial witness read and explained the Informed Consent Form (ICF) in the participant's preferred language. Thumb impressions were taken from illiterate subjects, and signatures were obtained from the impartial witnesses on the ICF. Subject identities were kept confidential, and the study data was coded to ensure privacy. The study results may be published in peer-reviewed scientific journals with the investigators' consent, without disclosing the identities of the participants.
[0050] Following ethics committee approval, the trial was registered on the CTRI website with registration number CTRI/2024/03/064117 (Registered on: 14/03/2024). Subject enrollment began only after the CTRI registration was completed.
[0051] CRITERIA- To ensure the study's relevance and reliability, specific inclusion and exclusion criteria were established for participant selection.
Inclusion Criteria:
Participants aged 18 to 60 years, both males and females
Individuals with mild to moderate perceived stress
Participants reporting impacts on alertness, memory, and energy levels
Individuals with stable chronic conditions not anticipated to disrupt study outcomes
Participants who voluntarily provided written informed consent

Exclusion Criteria:
Women who could become pregnant and were not using proper birth control
Pregnant or breastfeeding women
Participants with a history of heavy drug, alcohol, or tobacco use
Individuals with brain or nerve disorders
Participants who had recently undergone surgery or had sleep disorders
Any participants deemed unsuitable by the investigator due to other health problems.
[0052] Result of the study-
Demographic characteristics
[0053] All 30 participants (10 males and 20 females) successfully completed the study. The average age of the subjects was 47.13±10.27 years. Male participants had an average weight of 68.00 kg, a height of 166.40 cm, and a BMI of 24.72 kg/m². Female participants had an average weight of 65.20 kg, a height of 155.65 cm, and a BMI of 26.90 kg/m². These demographic details are summarized in the table below. All parameter data were analyzed using the independent student t-test at a p-value < 0.05 as shown below in Table 1.
Parameter Male Mean ± SD (n=10) Male SD Female Mean ± SD (n=20) Female SD P value
Average Age (Years) 43.40±15.07 15.07 49.00±16.52 16.52 0.163
Weight (kg) 68.00±9.57 9.57 65.20±12.85 12.85 0.548
Height (cm) 166.40±5.15 5.15 155.65±7.51 7.51 <0.001
BMI (kg/m2) 24.72±4.61 4.61 26.90±4.69 4.69 0.234
Table 1
Assessment of hematological and biochemical investigations-
[0054] The analysis of the hematological and biochemical parameters showed no statistically as well as clinically significant changes between the screening and day 30-time points, with the exception of a statistically significant increase was observed in the hematocrit (PCV) levels from screening (37.10 ± 5.62%) to day 30 (39.79 ± 5.70%) (p = 0.008).). All other blood parameters, including white and red blood cell counts, hemoglobin, liver function tests, and kidney function tests, remained stable and within the respective reference ranges throughout the study period. These findings indicate the study intervention did not have any clinically relevant impact on the participants' overall blood profile during the 30-day evaluation as shown below in Table 2. Further, Table 3 discloses kidney function test results. 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 Reference Range
White Blood Cell Count (WBC) 7240.00±1904.01 7140.33±1765.74 0.539 (4000 - 11000 cell/cu.mm)
Red Blood Cell Count (RBC) 4.50±0.65 4.70±0.59 0.271 (4.7 - 6.0 mil/cu.mm)
Hemoglobin (Hb) 12.13±1.62 12.35±1.39 0.176 (Female: 11.6 - 15 gm/dL & Male: 13.2-16.6 gm/dL)
Haematocrit (PCV) 37.10±5.62 39.79±5.70 0.008 (42 - 52 %)
Mean Corpuscular Volume (MCV) 83.23±11.91 81.57±9.56 0.364 (78 - 100 fL)
Mean Corpuscular Haemoglobin (MCH) 26.97±4.60 26.53±3.81 0.622 (27 - 31 pg)
Mean Corpuscular Haemoglobin Concentration (MCHC) 32.32±1.12 32.00±1.13 0.184 (32-36 gm/dL)
Platelet Count 278.60±74.37 280.90±73.47 0.79 (150 - 450 10^3/ul)
Neutrophils 55.13±6.45 56.53±7.11 0.124 (40 - 75 %)
Lymphocytes 35.90±6.80 34.50±4.94 0.097 (20 - 40 %)
Monocytes 5.17±1.66 5.13±1.50 0.786 (2-10 %)
Eosinophils 3.47±1.07 3.43±0.97 0.712 (1-6 %)
Basophils 0.00±0.00 0.00±0.00 1 (0-1 %)
Liver Function Protein Total 6.96±0.58 6.96±0.77 0.974 (6.0 - 8.3 g/dL)
Albumin 4.25±0.35 4.27±0.52 0.754 (3.2 - 5.5 g/dL)
Globulin 2.71±0.58 2.68±0.72 0.553 (1.8 - 3.6 g/dL)
A/G Ratio 1.63±0.39 1.71 ±0.55 0.136 (1.2 - 2.2)
Bilirubin Total 0.51±0.20 0.52±0.19 0.575 (0.1-1.2 mg/dL)
Bilirubin Direct 0.17±0.11 0.18±0.11 0.539 (0-0.4 mg/dL)
Bilirubin Indirect 0.34±0.15 0.33±0.15 0.864 (0.1-0.8 mg/dL)
Aspartate Transaminase (AST/SGOT)


26.33±9.91 25.96±9.48 0.694 (49 U/ L)
Alanine Transaminase (ALT/SGPT)
22.81±8.34 24.01±8.81 0.231 (49 U/ L)
Alkaline Phosphatase
108.18±42.48 110.48±41.33
0.177 (80 - 306 U/ L)

Table 2
Kidney Function
Parameter Screening (Mean ± SD) Day 30 (Mean ± SD) p-Value Reference Range
Urea 24.03±7.03 mg/dL 24.26±6.75 mg/dL 0.799 7-40 mg/dL
Creatinine 0.82±0.19 mg/dL 0.79±0.21 mg/dL 0.231 0.5-1.5 mg/dL
Uric Acid 4.70±1.06 mg/dL 4.66±0.98 mg/dL 0.43 3.0 to 7.2 mg/dL
Table 3
Assessment of vital signs
[0055] The study results showed a statistically significant decrease in systolic blood pressure (p = 0.035) and body temperature (p < 0.001) from screening to day 30. However, the changes observed in diastolic blood pressure, heart rate, and respiratory rate were not statistically significant as shown below in Table 4. 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.
Parameter Screening (Mean ± SD) Day 30 (Mean ± SD) p-Value
Systolic Blood Pressure (mmHg) 121.87±7.27 118.33±7.00 0.035
Diastolic Blood Pressure (mmHg) 75.83±7.22 76.93±6.01 0.425
Heart Rate (beats per minute) 74.77±7.93 75.27±9.76 0.81
Body Temperature (°F) 97.90±0.71 97.06±0.75 <0.001
Respiratory Rate (breaths per minute) 16.97±0.85 17.47±1.22 0.094
Table 4
Assessment of adverse events-
[0056] The adverse events observed during the study are presented in Table 5. Out of the 30 participants, a total of 3 subjects (10%) experienced at least one adverse event. The most commonly reported adverse events were fever and headache. For each adverse event, the number of subjects affected and the corresponding rescue medication used are shown. Adverse events’ observed were not related to investigational product.
Adverse Events No Rescue Medication (N=30) Rescue Medication
Headache 2 Paracetamol, Aspirin
Fever 1 Paracetamol
Total No. of Events 2
Total No. of subjects (%) 3 (10%)
Table 5
Assessment of mental alertness, memory and perceived energy by 4-point Liberty Scale:
[0057] The subjects' self-reported assessments of alertness, memory, and perceived energy were evaluated using a 4-point Likert scale (0-worsened, 1-not improved, 2-improved, 3-improved satisfactory) at screening and on day 30. The results showed statistically significant improvements in all three parameters from screening to the end of the study period.
[0058] At the screening, 27 subjects reported worsened alertness and memory. After 30 days of treatment, all participants (100%) reported increased alertness and memory, transitioning to the improved-satisfactory category. Likewise, 28 subjects reported worsened energy levels at the screening; however, after 30 days of treatment, all participants (100%) exhibited improvement in their perceived energy levels.
[0059] These findings suggest that the administration of these servings for 30 days resulted in clinically meaningful improvements in the subjects' self-reported alertness, memory, and perceived energy levels compared to the baseline assessments as shown in Table 6. Data is represented as Mean ± S.D. Within group analysis was done by using the dependent student t-test and Wilcoxon signed rank test. Significant at p< 0.05.
Parameter Score Screening (n=30) Day 30 (n=30)
Alertness 0 (Not Alert) 27 0
1 (Somewhat Alert) 3 0
2 (Moderately Alert) 0 23
3 (Very Alert) 0 7
Memory 0 (Poor Memory) 27 0
1 (Somewhat Forgetful) 3 0
2 (Good Memory) 0 24
3 (Excellent Memory) 0 6
Perceived Energy 0 (No Energy) 28 0
1 (Low Energy) 2 0
2 (Moderate Energy) 0 23
3 (High Energy) 0 7
Table 6
[0060] Therefore, the nutraceutical formulation as disclosed in the present invention has improved synergistic effects over the formulation disclosed in the prior art documents. The nutraceutical formulation focuses on cognitive function and stress management, ensuring a synergistic effect that promotes overall mental well-being. The inclusion of Blueberry extract, which is rich in antioxidants and supports cognitive function, distinguishes this formulation from others that do not leverage such nootropic benefits. Ashwagandha provides dual benefits in stress alleviation and cognitive enhancement. The use of Saffron extract, which has been shown to have mood-enhancing effects, further enhances the formulation's effectiveness. This combination of ingredients, along with essential vitamins, creates a comprehensive solution that addresses both cognitive and stress-related issues.
[0061] Further, the nutraceutical formulation avoids the use of artificial colors and added sugars, making it a healthier and more appealing option compared to many existing products in the market. The specific blend of ingredients and their synergistic effects provide a novel approach to cognitive enhancement and stress management, offering quick and convenient relief without the drawbacks associated with caffeine or habit-forming substances
[0062] 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.
[0063] 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.
[0064] While various aspects and embodiments have been disclosed herein, other aspects and embodiment will be apparent to those skilled in the art.
 
, C , Claims:We Claim:
1. A nutraceutical formulation for improving mental focus and reducing stress, the nutraceutical formulation comprising:
a blend of EnXtra (Alpinia galanga) extract;
Saffron (Crocus sativus L.) extract;
Vitamin B3 (Nicotinamide);
Vitamin B6 (Pyridoxine Hydrochloride);
Vitamin B12 (Cyanocobalamin);
Ashwagandha Root (Withania somnifera) extract;
Blueberry (Vaccinium corymbosum) extract; and
pharmaceutically acceptable excipients.
2. The nutraceutical formulation as claimed in claim 1, wherein pharmaceutically acceptable excipients further comprise:
a diluent comprises a component selected from a group of Starch, Microcrystalline cellulose, Lactose, Carboxymethyl cellulose, Calcium phosphate, Crospovidone, Hydroxypropyl cellulose, Magnesium stearate, Mannitol, Sucrose, Acacia, Calcium stearate, Ethylcellulose, Gelatin, Polyethylene glycol, Polysorbate 80, Povidone, or Sodium starch glycolate;
a stabilizer comprises a component selected from a group of Povidone (PVP), Polyvinyl alcohol (PVA), Polyethylene glycol (PEG), Hypromellose (HPMC), Hydroxypropyl cellulose (HPC), Hydroxyethyl cellulose (HEC), Carboxymethylcellulose sodium (NaCMC), Docusate sodium (SD), Sodium lauryl sulfate (SLS), Polyethylene imine (PEI), D-α- tocopheryl polyethylene glycol succinate (TPGS), Polyethylene oxide (PEO), CrosPovidone, or Polypropylene oxide (PPO);
an anti-caking agent comprises a component selected from a group consisting of Sodium aluminosilicate, Calcium silicate, Sodium dioxide, Powdered cellulose, Magnesium stearate, Sodium bicarbonate, Sodium ferrocyanide, Potassium ferrocyanide, Tricalcium phosphate, or Yellow prussiate of soda; and
a capsule shell comprises a component selected from a group consisting of Mannitol, Hydroxypropyl methylcellulose, Microcrystalline cellulose, Lactose, Pregelatinized starch 1500, or Corn starch.
3. The nutraceutical formulation as claimed in claim 1, wherein the formulation comprises:
the EnXtra (Alpinia galanga) extract in an amount ranging from 15.00% to 25.00% by weight per capsule;
the Saffron (Crocus sativus L.) extract in an amount ranging from 1.50% to 2.50% by weight per capsule;
the Vitamin B3 (Nicotinamide) in an amount ranging from 0.75% to 1.50% by weight per capsule;
the Vitamin B6 (Pyridoxine Hydrochloride) in an amount ranging from 0.10% to 0.25% by weight per capsule;
the Vitamin B12 (Cyanocobalamin) in an amount ranging from 0.0001% to 0.0003% by weight per capsule;
the Ashwagandha Root (Withania somnifera) extract in an amount ranging from 12.00% to 18.00% by weight per capsule; and
the Blueberry (Vaccinium corymbosum) extract in an amount ranging from 30.00% to 35.00% by weight per capsule.
4. The nutraceutical formulation as claimed in claim 2, wherein the pharmaceutically acceptable excipients further comprise:
the diluent in an amount ranging from 5-10% by weight per capsule;
the stabilizer in an amount ranging from 1-5% by weight per capsule;
the anti-caking agent in an amount ranging from 0.01-5% by weight per capsule; and
the capsule shell in an amount ranging from 10-20% by weight per capsule.