Description:FIELD OF INVENTION
The present invention belongs to the pharmaceutical field and deals with a herbal tablet formulation. More specifically this invention relates to a herbal tablet formulation for better mental health and process of its preparation.
BACKGROUND OF INVENTION
Anxiety is a psychological and physiological condition that has many different characteristics, including cognitive, emotional, behavioural, and physical. The word "anxiety" is actually derived from the Latin verb "ango," which meaning "to vex or torture," whether or not there is any psychological stress present. Moreover, it may induce feelings of apprehension, fear, and unease. It is sometimes regarded as a typical response to a stressor. A significant mental disease called anxiety causes a variety of functional impairments that have societal implications.
There are 4 types of anxieties:
• Generalized anxiety disorder
• Specific phobias
• Social anxiety
• Panic disorder

For the treatment of anxiety, a variety of medications, both synthetic and natural, are used. Many synthetic items can irritate the skin and cause rashes and erythema. Herbs such as Citrus paradise, A. arvensis L., C. nepeta L., C. monogyna Jacq., H. lupulus L., L. nobilis L., L. angustifolia Mill., M. sylvestris L., M. chamomilla L., M. officinalis L., O. basilicum L., P. rhoeas L., P. somniferum L., R. officinalis L., T. platyphyllus Scop., and V. officinalis L as well as synthetic compounds such as Benzodiazepines like Diazepam, Chlordiazepoxide, Alprazolam, Betablockers like Propranolol and H1 Anti- histamine like Hydroxyzine, are used to treat anxiety.
Up to 33.7% of people will experience an anxiety disorder at some point in their lives, according to large population-based surveys. There is a clear under diagnosis and under treatment of many disorders. According to the study, there has been no change in the prevalence rates of anxiety disorders in recent years. In cross-cultural comparisons, prevalence rates are quite variable. Cultural influences are less likely to be the cause of this heterogeneity than methodological variances. Although they have a long history, anxiety disorders naturally become less common as people age. Multiple mental illnesses as well as other anxiety disorders frequently co-occur with anxiety disorders.
Prior art document US8741319B2 discloses a method and composition for reducing distress dysfunction, including emotional and physical distress. The invention entails co-administration of at least one Receptor Switcher and at least one Endorphin Enhancer. Additionally, at least one Synergistic Enhance and/or at least one Exogenous Opioid are also administered to enhance or prolong the therapeutic effects.
Prior art document CN114949148A discloses an anxiolytic traditional Chinese medicine composition and a preparation method and application thereof. The anxiolytic traditional Chinese medicine composition is prepared by using Curcumae radix , Radix paeoniae alba, Acori graminei Rhizoma, Bambusae caulis in Taeniam, fermented soybean, Fructus gardeniae, Radix ophiopogonis and fried spina date seeds as raw materials. All the components play a role in synergy. The traditional Chinese medicine composition has the effects of soothing the liver, relieving depression and resolving phlegm for tranquilization, and is suitable for generalized anxiety disorder. The traditional Chinese medicine composition is prepared by extracting with water as a solvent, the method is simple and easy to operate. The production efficiency of a water extraction process is high and the extraction rate of paeoniflorin can reach 21.25%, and the cream yield can reach 23.86%.
Prior art document US8329227B2 discloses a formulas for producing compositions for the structural/functional nutritional support for those who struggle with poor focus, concentration and/or memory. In addition, the present invention provides compositions comprising nutritional/botanical factors helpful to those who subjectively experience transient mental fatigue or poor cognitive function. The compositions of this invention consist primarily of the following ingredients B-complex vitamins, antioxidants, minerals, phosphatidyl serine (PS), choline, dimenthyl-aminoethanol (DMAE), docosahexaenoic acid (DHA), L-pyroglutamic acid, as well as herbal extracts from Bacopa monniera, Vinca minor, and Huperzia serrata. The present invention also relates to the administration of these compounds to alleviate mental fatigue or poor cognitive function.
From above prior art disclosures it is visible that there are a number of compositions and methods for treating or providing relief from anxiety and induced symptoms. Although presently available compositions have their own benefits and shortcomings but there is still a need for a more effective and better composition which is target directed, have prolonged drug release and lesser side effects and which is very cost effective also.
OBJECT OF THE INVENTION
The main object of the present invention is to provide a herbal formulation for better mental health.
Another principle object of present invention is to provide a herbal tablet formulation which reduces the anxiety and provides a better mental health.
Another important object of present invention is to provide a process for preparation of herbal tablet formulation which reduces the anxiety and provides a better mental health.
SUMMARY OF INVENTION
The principle embodiment of the present invention provides a herbal tablet formulation which reduces the anxiety and provides a better mental health.
A further embodiment of present invention discloses herbal tablet formulation comprising herbs Rauvolfia serpentina 160-240 mg, Asparagus racemosus 80-120 mg ,Withania somnifera 80-120 mg, Centella asiatica 80-120 mg, Acorus calamus 40-60 mg ,Convolvulus prostrates 20-60 mg, Nigella sativa 30-70mg, Glycyrrhiza glabra Linn. 64-96mg, Tinospora cordifolia 64-96mg ,Adhatoda vasica 24-36mg, Nardostachys jatamansi DC 16-24mg,Quercus infectoria 40-60mg; and Mukta pishti 80-120 mg as active pharmaceutical ingredient; and Gum Acacia100mg as binder .
Another embodiment of present invention discloses herbal tablet formulation wherein 1000mg tablet preferably comprises Rauvolfia serpentina 200 mg, Asparagus racemosus 100 mg ,Withania somnifera 100 mg, Centella asiatica 100 mg, Acorus calamus 50 mg ,Convolvulus prostrates 40 mg, Nigella sativa 50 mg, Glycyrrhiza glabra Linn. 80 mg, Tinospora cordifolia 80 mg ,Adhatoda vasica 30 mg, Nardostachys jatamansi DC 20 mg, Quercus infectoria 50 mg, Mukta pishti 100 mg and Gum Acacia100mg.
Another important embodiment of present invention discloses a process for preparation of tablet formulation is prepared by a process comprising steps;
a. taking different raw herbs in preferred amount and check them for any impurity and foreign matters;
b. steam sterilizing the raw herbs for 15 to 20 minutes;
c. drying raw herbs by tray dryer for 1 hour;
d.grinding all herbs together in a grinder to make fine powder;
e.adding ground Mukta pishti to blend of step (d) and mix thoroughly in conical mixer;
f.passing herbal powder blend through rotary magnet and then passing through sieve no.100;
g. adding 100 mg Gum acacia(q.s) and 10% distilled water in above blend of step (f);
h.forcing wet mass by wet granulation with sieve no. 20;
i.drying wet granules in tray dryer at 600C temperature for 3-4 hrs;
j.dry sieving through 20 no. mesh;
k.punch through 55 station rotary tablet press machine to make tablets; and
l.using magnetic separator to check metal adulteration from tablet as part of quality check before packaging.
BRIEF DESCRIPTION OF DRAWINGS
Figure 1 shows graphical representation of behavioral analysis using novel diving tank & light and dark chamber test apparatus.
Figure 2A shows graphical representation of anxiety score for treatment group with tablet of present invention and Figure 2B shows anxiety score of placebo group inform of anxiety vs visit plot and means plot of anxiety.
Figure 3A shows graphical representation of SGA- Depression score for treatment group with tablet of present invention and Figure 3B shows SGA- Depression score of placebo group, inform of depression vs visit plot and means plot of depression.
Figure 4A shows graphical representation of SGA-Insomnia score for treatment group with tablet of present invention and Figure 4B shows SGA-Insomnia score of placebo group, inform of insomnia vs visit plot and means plot of insomnia.
Figure 5A shows graphical representation of SGA-Hot flushes score for treatment group with tablet of present invention and Figure 5B shows SGA-Hot flushes score of placebo group, inform of hot-flushes vs visit plot and means plot of hot-flushes.
Figure 6A shows graphical representation of SGA-Headache score for treatment group with tablet of present invention and Figure 6B shows SGA- Headache score of placebo group, inform of Headache vs visit plot and means plot of Headache.
Figure 7A shows graphical representation of SGA-Memory loss score for treatment group with tablet of present invention and Figure 7B shows SGA- Memory loss score of placebo group, inform of Memory loss vs visit plot and means plot of Memory loss.
Figure 8A shows graphical representation of SGA-Night sweat score for treatment group with tablet of present invention and Figure 8B shows SGA- Night sweat score of placebo group, inform of Night sweat vs visit plot and means plot of Night sweat.
Figure 9A shows graphical representation of SGA- Tiredness score for treatment group with tablet of present invention and Figure 9B shows SGA- Tiredness score of placebo group, inform of Tiredness vs visit plot and means plot of Tiredness.
Figure 10A shows graphical representation of SGA- irritability score for treatment group with tablet of present invention and Figure 10B shows SGA- irritability score of placebo group, inform of irritability vs visit plot and means plot of irritability.
Figure 11A shows graphical representation of SGA- mood swings score for treatment group with tablet of present invention and Figure 11B shows SGA- mood swings score of placebo group, inform of mood swings vs visit plot and means plot of mood swings.
Figure 12A shows graphical representation of SGA- MENQOL score for treatment group with tablet of present invention and Figure 12B shows SGA- MENQOL score of placebo group, inform of MENQOL vs visit plot and means plot of MENQOL.
Figure 13A shows graphical representation of SGA- QOL score for treatment group with tablet of present invention and Figure 13B shows SGA- QOL score of placebo group, inform of QOL vs visit plot and means plot of QOL.

DETAILED DESCRIPTION
In describing the embodiments of the invention, specific terminology is resorted for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. As used in the present specification the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise.
Illustrative embodiments of the invention now will be described more fully hereinafter with reference to the examples, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.
At present nearly 34% of people experience an anxiety disorder at some point in their lives, according to large population-based surveys. There is a clear under diagnosis and under treatment of many disorders. According to the study, there has been no change in the prevalence rates of anxiety disorders in recent years. In cross-cultural comparisons, prevalence rates are quite variable. Cultural influences are less likely to be the cause of this heterogeneity than methodological variances. Although they have a long history, anxiety disorders naturally become less common as people age. Multiple mental illnesses as well as other anxiety disorders frequently co-occur with anxiety disorders.
Present invention discloses a herbal tablet formulation for treatment of anxiety disorders. The present formulation comprises following ingredients given in Table-1.
Table 1: Showing ingredients used in present invention

Present tablet contains many active ingredients like Mukta Pishti(white pearl) which is widely used in the Hyperacidity, anxiety, fever, burning sensation etc, Rauvolfia serpentina has anti-stress, anti-aging and life strengthening activities, Climbing Ayurvedic plant Asparagus racemosus is well-known for its therapeutic effects on a variety of conditions, including hyperlipidemia, hypertension, angina, dysmenorrhea, anxiety disorders etc. Withania somnifera is effective for treating a wide range of problems of the central nervous system (CNS), especially epilepsy, stress, and neurodegenerative illnesses like Parkinson's and Alzheimer's disease, among others, Centella asiatica for cognitive properties as a brain tonic, in the treatment of mental disorders, and as a memory-enhancing agent etc. Acorus calamus show therapeutic properties in metabolic and neurological disorders, such as anticonvulsant, antidepressant, antihypertensive, anti-inflammatory etc., Convolvulus prostratus has various pharmacological activity including CNS depression, anxiolytic, tranquillizing, insomnia, antidepressant, antistress, etc . Nigella sativa used in neurological and psychiatric problems, e.g., the control of pain, Parkinsonism, epilepsy and anxiety, as well as improvement of memory, alertness, elevation of mood and feeling of good health, etc. Yashtimadhuor glycyrrhiza glabra have been employed clinically for their anti- inflammatory, antiulcer expectorant, antimicrobial and anxiolytic activities. Guduchi or Tinospora cordifolia in countering various disorders and usages as anti-oxidant, anti-hyperglycemic, antihyperlipidemic, hepatoprotective, cardiovascular protective, neuroprotective, osteoprotective, radioprotective, anti-anxiety, etc. Adhatoda vasica, has a long history of usage for the treatment of many acute and chronic illnesses, and studies have shown that it is particularly effective for bacterial infections, coughs, bronchial infections, reproductive abnormalities, heart diseases, and many other conditions. Jatamansi used in depression and anxiety related problems and Qurecus infectoria used as multiple biological activities including anti-inflammatory, anti-bacterial, hepato-protective, anti-diabetic, anticancer, gastro-protective, antioxidant, etc.
PREPARATION OF FORMULATION
For preparation of present formulation different herbs were taken in quantity range given in Table-2 below for a 1 gm tablet.
Table2: Showing list of different herbs , their parts used and their amount in 1000mg tablet
Sr. No. Ingredients (Botanical Name) Common Name Part used Quantity
1. Mukta pishti white pearl Pearl 80-120mg
2. Rauvolfia serpentina Sarpagandha Root 160-240mg
3. Asparagus racemosus Satavari Root 80-120mg
4. Withania somnifera Ashwagandha Root 80-120mg
5. Centella asiatica Brahmi Leaves 80-120mg
6. Acorus calamus Vacha Stem 40-60mg
7. Convolvulus prostrates Shankhpushpi Whole plant 20-60mg
8. Nigella sativa Kalonji Seed 30-70mg
9. Glycyrrhiza glabra Linn. Mulethi Stem 64-96mg
10. Tinospora cordifolia Guduchi Stem 64-96mg
11. Adhatoda vasica Malabar nut Fruit 24-36mg
12. Nardostachys jatamansi DC Jatamansi Whole plant 16-24mg
13. Quercus infectoria Majufal Fruit 40-60mg

The most suitable and effective quantity for different herbs used in present tablet formulation is given in table 3 below.
Table-3: Best and most suitable concentration of different herbs used in 1000mg tablet.
Sr. No. Ingredients(Botanical Name) Common Name Part used Quantity
1. Mukta pishti white pearl Pearl 100mg
2. Rauvolfia serpentina Sarpagandha Root 200mg
3. Asparagus racemosus Satavari Root 100mg
4. Withania somnifera Ashwagandha Root 100mg
5. centella asiatica Brahmi Leaves 100mg
6. Acorus calamus Vacha Stem 50mg
7. Convolvulus prostrates Shankhpushpi Whole plant 40mg
8. Nigella sativa Kalonji Seed 50mg
9. Glycyrrhiza glabra Linn. Mulethi Stem 80mg
10. Tinospora cordifolia Guduchi Stem 80mg
11. Adhatodavasica Malabar nut Fruit 30mg
12. Nardostachys jatamansi DC Jatamansi Whole plant 20mg
13. Quercus infectoria Majufal Fruit 50mg

The present tablet formulation was prepared by following process:
1. Take different raw herbs in amount given in table 2 and check them for any impurity and foreign matters.
2. Steam sterilize the raw herbs for 15 to 20 minutes.
3. Dry raw herbs by tray dryer for 1 hour.
4. Grind all herbs together in a grinder to make them fine powder.
5. Add ground Mukta pishti to the above mix and mix thoroughly in conical mixer.
6. Pass herbal powder blend through rotary magnet and then pass through sieve no.100.
7. Add 100 mg Gum acacia(q.s) and 10% distilled water in above blend.
8. Force the wet mass by wet granulation with sieve no. 20.
9. Drying the wet granules in tray dryer at 60 degree Celsius temperature for 3-4 hrs.
10. Dry sieving through 20 no. mesh.
11. Punch through 55 station rotary tablet press machine to make tablets.
12. Use Magnetic separator to check metal adulteration from tablet as part of quality check before packaging.
EFFECT OF TABLET AGAINST ANXIETY
MATERIAL AND METHODS:
The trial was carried out at Department of Pharmacology and Pharmaceutics, Meerut Institute of Engineering and Technology, Meerut. The investigational product called Menoveda Akira Tablets were provided by Menoveda life sciences llp. The Batch Number was MEAK-01, and it was stored at room temperature.
Preparation of Animals:
Adult zebrafish (Danio rerio) were randomly selected, weighed, and divided into different groups. A total of seven groups were formed with twelve fishes in each group (Given below). The fishes were kept in the acclimatization period for 14 days prior to dosing in the laboratory conditions maintaining normal room temperature.
Grouping of Animals:
Animals were grouped as shown in table 4 below.

Preparation of test drug:
Test drug was dissolved in the purified water just prior to the dose administration.
Drug administration:
Four doses 1mg/L, 2.5mg/L, 5 mg/Land 10mg/L for n=6 fishes per liter water were chosen, respectively. Oral route of drug administration was performed.
Mortality observation:
The numbers of animal deaths were observed at days 7th , 9th , 12th , 15th and 17th after drug
administration.
General Clinical observation:
Post drug administration, the animals were continuously observed for the behavioral activity (Locomotion, muscle coordination, time spent in specific zone, number of entries) in comparison to zebra fish behavioral models.
Body weight Measurement:
The body weight was measured on day 0 (prior to drug administration) and day 7 (post study) using electrical balance.
Biochemical analysis:
At the end of the observation period, the survived animals were sacrificed by cryoanaesthesia and were subjected to biochemical analysis. All biochemical analysis changes were recorded.
Study Design
The study was conducted in accordance to the CPCSEA (711/PO/Re/S/02/CPCSEA) Guidelines and reference research paper for the testing of experimental fishes to evaluate the efficacy of Anti-Anxiety Efficacy of Polyherbal Formulation i.e., Menoveda Akira Tablets on Zebra fish Model.
The test sample was dissolved in the purified water, and four pre specified fixed-doses (1mg/L,2.5mg/L,5mg/L and10mg/L) was orally administered in adult zebra fish (approx. 3
months old) by directly dissolving test sample in to water. The body weight of animals was
measured at day 0 (before the drug administration) and on day 7 (post study). The rate of mortality and general behavior of the animals were observed continuously for the initial 1, 4,and 24 h after the drug administration and then daily for 7 days. Behavioral parameters were performed by using novel diving tank test and light & dark chamber test. After behavioral analysis, biochemical analysis was examined.
In the study, no mortality was observed up to 7 days for 1mg/L, 2.5mg/L, 5mg/L and 10mg/L,respectively. No toxic symptoms were found in zebrafish in all four doses. No abnormalities were observed in general clinical observations or gross necropsy. The normal zebra fish were found to show vigilant behavioral activity with variation in locomotor, behavioral, neurological, or biochemical results when compared to the disease done. No significant changes were observed in the body weight of zebra fish in all four treated doses.
Considering the data obtained from the study, the anti-anxiety drug is effective at the doses of 2.5, 5 and 10mg/L. The drug was found to be in-effective at a dose of 1mg/L.
RESULT AND DISCUSSION
Mortality:
No mortality was observed in any animals until 7 days post drug administration for all the treatment doses.
Clinical signs:
No abnormalities were observed in any animals until 7 days after the drug administration for all the treatment doses.
Body Weight:
No significant variation has been observed. Weight gain or weight loss in the study can not
be considered a sign of presence of Anxiety disease.
Macroscopic Findings:
No abnormalities were observed in any zebra fish at 1, 2.5, 5 and 10mg/L dose.
Biochemical analysis:
Test sample possess antioxidant properties. In present study, it was observed that in zebra fish undergone Acute Undetermined Stress (AUS), there is increase in LPO, AChEs and Nitrite levels where as decline in levels of GSH. With zebra fish undergone treatment using test sample, there is decrease in LPO, AChEs and Nitrite levels whereas increase in levels of GSH.
Behavioural analysis:
Behavioural analysis of test samples were done using a Novel Diving Tank Test Apparatus and Light and Dark chamber test. Figure 1 shows the schematic arrangement for these tests.
Behavioral Analysis using Novel Diving Tank Test Apparatus indicating that normal fishes preferring top zone as against the anxiety induced fishes that prefer the Bottom Zone. The fishes were observed for 10 minutes and the observed results are given below in table 5 and 6.
Behavioral Analysis using Light-Dark Chamber Test Apparatus indicated that normal fishes preferring light zone as against the anxiety induced fishes that prefer the dark Zone. The fishes were observed for10 minutes and the observed results are given in table 7 and 8.
Table 5: showing behavioural analysis in novel diving tank test in top zone.

Table 6: showing behavioural analysis in novel diving tank test in bottom zone.

Table 7: showing behavioural analysis in light and dark chamber test in light chamber.

Table 8: showing behavioural analysis in light and dark chamber test in dark chamber.

CONCLUSION:
In the present research, the work was done on efficacy of tablet of present invention with the help of various parameters and the behavioral activity was done by using Novel Diving tank test & Light- Dark chamber test. According to the study's findings, Menoveda Akira Tablets have antioxidant activity, lowers LPO, AChEs& Nitrite Levels, Improves GSH and there was no mortality and abnormalities seen throughout the examination. So, this product can be used to treat stress conditions such as Neuro, Behavioral and Oxidative.
EFFECT OF TABLETS OF PRESENT INVENTION ON FEMALES WITH MENOPAUSE RELATED MENTAL HEALTH ISSUES
Menopause is the time that marks the end of your menstrual cycles. It's diagnosed after you've gone 12 months without a menstrual period. Menopause can happen in your 40s or 50s, but the average age is 51 in the United States and between 45 and 55 yr. of age in India. Menopause is a natural biological process. But the physical symptoms, such as hot flashes, and emotional symptoms of menopause may disrupt your sleep, lower your energy or affect emotional health. There are many effective treatments available, from lifestyle adjustments to hormone therapy. The production of oestrogens and androgens is modulated during the menopause, which is characterized by a variety of physical changes in women. Although the ovaries play a significant role in peri and postmenopausal women's testosterone synthesis, the adrenal glands' contribution to the testosterone pro-hormone pool plummets to the point where the ovaries are unable to make up the difference.
In the months or years leading up to menopause (perimenopause), you might experience these signs and symptoms:
- Hot flashes
- Night sweats
- Sleep problems
- Mood changes
- Anxiety
- Depression
- Memory loss.

Material and Methods:
The trial was carried out at Shree Ram Hospital, Meerut under the direction of Dr. Shikha Sharma, and the product of present invention was provided by Menoveda Life sciences Pvt Ltd. Without making any distinctions based on caste or other factors, all of the females were included in the study after meeting the eligibility requirements.
Ethical Consideration:
The trial must be executed in accordance with the protocol and the applicable laws and regulatory requirements of the pertinent regulatory agency. The study must be executed in compliance of ethical principles emerging from the Declaration of Helsinki and amendments and the ICH-GCP guidelines. Inclusion criteria-
- Females from 45 to 70 years of age, post Menopause.
- Females suffering from one or multiple mental health issues from- anxiety, insomnia, depression etc.
- Females that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- Females willing to avoid participation in any other interventional clinical trial for the duration of the study.
Exclusion criteria-
- Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- Females that have participated in any other interventional clinical trial in the previous 30 days.
- Females with known sensitivity to any of the constituents of the investigational product.
Selection of subject:
According to the study protocol, which includes inclusion and exclusion criteria, 60 subjects participated in the study. This study was conducted by a certified researcher with a confirmed diagnosis of the Menopause related mental health issues.
Dose and Duration:
The subjects consumed one tablet orally twice a day and for the duration of 30 days.
Selection and Identification of subject
Subjects were enrolled between the ages of 45 to 70 years with diagnosed by the investigator. After that, you will be provided with a test product after enrollment.
Study Design
This is a randomized, double-blind, placebo controlled, designed to evaluate the safety, tolerability, and efficacy of present Tablets when administered for up to 30 days to females between the ages of 45to 70 years who have a menopause related mental health issues. Trial subjects were enrolled at 1 investigative site in India. Approximately 60 subjects who meet the trial entry criteria was randomly assigned in a 1:1 ratio to receive either present Tablets or Placebo tablet. The subjects consumed tablet orally twice a day and for the duration of 30 days. The maximum duration of the trial for each subject was approximately 30 days after being provided with the written informed consent, then the subject will undergo screening procedures. At the end of the screening period the eligible subjects will be included in the trial and the ineligible will be excluded from the trial. During the treatment period, subjects returned to the trial site according to the trial schedule for the assessment of the compliance with the treatment regimen, concomitant medications and the adverse events (AEs). During the treatment period the investigator will assess the severity of the patient’s disease by using the SGA, MENQOL, QOL (DASS-21) and the subjects will be asked to fill the form before screening of the trial and all the safety assessments will be done during the treatment period and at the end of the trial the subjects will be asked to fill the same SGA, MENQOL(Menopause-Specific Quality of Life questionnaire) , QOL (DASS-21) so that the efficacy of the product on the subject could be determined .
Assessment criteria
All the subjects were explained the process, its benefits, possible side effects, and compensation policy & informed consent were received prior to enrollment in the trial/study. During Screening details were collected regarding the menstruation history of patient but special emphasis was given on the mental health to rule out the patients. There were various examination performed such as Physical, demographic, medical history and diary were dispensed with instruction to subject.
Efficacy parameter
The efficacy of the product is determined by a number of factors. The study included a number of variables to assess the severity of mental health during menopause, one of which was Anxiety, depression.
Effectiveness may be revealed by:
SGA which include many factors such as;The SGA- Anxiety has improved, The SGA- Depression has improved,The SGA- Night sweats has improved,The SGA- Hot flushes has improved,The SGA- Mood swings has improved,The SGA-Irritability has improved,The SGA-Tiredness has improved,The SGA-Memory loss has improved,The SGA-Headache has improved, MENQOL has improved between the initial examination and the 30th day, Reduction of QOL between the baseline and the 30th day Quantitative study done with all the efficacy parameters such as demographic and assessment scoring. The data extracted from the comparison of initial visit to the final visit with all the comparative measures. The result disclosed on the basis of statistical data identified by the patient details.
Investigation:
In order to examine the patient's health status, SGA score was taken with factors such as - SGA- Anxiety, Depression, Insomnia, Hot flushes, Headache, Night sweats, Memory loss, Tiredness, irritability and mood swings along with reduction in secondary factor such as MENQOL and QOL.
Statistical analysis:
For the analysis of the effectiveness endpoints, all of the completed patients were taken into account. At the conclusion of the trial, the t-test was used to examine the Primary Endpoints. The mean values for the number of daily episodes for each therapy, the mean difference, the 95 percent confidence interval, and the two-sided p-value were given. We employed means, medians, and analyses for time recorded by chronometer to show that the results were robust and consistent regardless of the analysis method. Along with the median time, the one-way anova test and p value for the treatment comparison were presented. The analysis was done with NCSS software and validated with R software. The outcome/results with the p-value below 0.001 were considered significant.
Result and Discussion Subject disposition:
Out of 66 subjects were screened, 6 were found screen failures, No one dropout. 60 subjects who underwent the full treatment. Patient deposition detail is shown in table 9 below:
Table 9: Patient deposition detail

Demographic and Other Baseline Characteristics
The mean age of the subjects was 47.8 years in the Test group and 50.5 years in the Placebo group in the study. The mean height of the subjects was 161.66cm in the Test group and 159.26cm in Placebo group. The mean weights of the subjects were 65.3 kg in the Test group 76 kg and in the Placebo group. The BMI of the subjects were 24.90 in the Test group and 30.11 in the Placebo group.Result is shown in Table 10 below.

Table 10 : : Demographic characteristics
EFFICACY RESULTS AND TABULATIONS OF INDIVIDUAL PATIENT DATA A. Change in SGA score
I. SGA for Anxiety:
The mean of SGA- Anxiety score was1.86 and 0.53 in the Treatment group whereas it was2.13 and 1.86in the placebo group. The results show that the SGA- Anxiety score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 11 and figure 2A and 2B.
Table11: SGA- Anxiety Assessment

II. SGA for Depression:
The mean of SGA- depression score was 1.66 and 0.56 in the Treatment group whereas it was1.8 and 1.66in the placebo group. The results show that the SGA- Depression score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 12 and figure 3A and 3B. Table 12: SGA- depression assessment

III. SGA for Insomnia
The mean of SGA- Insomnia score was 1.26 and 0.43 in the Treatment group whereas it was1.36 and 1.3 in the placebo group. The results show that the SGA-Insomnia score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 13 and figure 4A and 4B.
Table 13: SGA- Insomnia Assessment

IV. SGA for Hot Flushes
The mean of SGA- Hot flushes score was 1.53 and 0.43 in the Treatment group whereas it was1.53 and 1.43 in the placebo group. The results show that the SGA-Hot flushes score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 14 and figure 5A and 5B. Table 14: SGA- Hot flashes Assessment
V. SGA for Headache
The mean of SGA- Headache score was 1.3 and 0.36 in the Treatment group whereas it was 1.4 and 1.33 in the placebo group. The results show that the SGA-Headache score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 15 and figure 6A and 6B. Table 15: SGA- Headache Assessment
VI. SGA for Memory loss The mean of SGA- Memory loss score was 0.93 and 0.5 in the Treatment group whereas it was 0.93 and 0.93 in the placebo group. The results show that the SGA-Memory loss score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 16 and figure 7A and 7B. Table 16: SGA- Memory loss Assessment

VII. SGA for Night Sweats
The mean of SGA- Nights sweats score was 1.26 and 0.3 in the Treatment group whereas it was 1.16 and 1.4 in the placebo group. The results show that the SGA-Night sweats score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation is given in Table 17 and figure 8A and 8B.
Table 17: SGA- Night sweat Assessment

VIII. SGA for Tiredness The mean of SGA- Tiredness score was 1.46 and 0.86 in the Treatment group whereas it was 1.56 and 1.4 in the placebo group. The results show that the SGA-Tiredness score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 18 and figure 9A and 9B.
Table 18: SGA- Tiredness Assessment

IX. SGA for Irritability
The mean of SGA- Irritability score was 1.33 and 0.4 in the Treatment group whereas it was 1.33 and 1.33 in the placebo group. The results show that the SGA-irritability score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 19 and figure 10A and 10B.

Table 19 : SGA- Irritability Assessment
X. SGA for Mood Swings The mean of SGA- Mood swings score was 1.5, and 0.46, in the Treatment group whereas it was 1.53 and 1.46 in the placebo group. The results show that the SGA-Mood Swings score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 20 and figure 11A and 11B. Table 20: SGA- Mood swing Assessment
B. Change in MENQOL Score: The mean MENQOL score were 78.16, and 45.43, in the Treatment group whereas it was 77.5 and 75.23 in the placebo group. The results show that the MENQOL score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 21 and figure 12A and 12B.
Table 21: MENQOL Assessment

C. Change in QOL (DASS-21)
The mean QOL score were 34.63 and 15.63 in the Treatment group whereas it was 36.26 and 33.56 in the placebo group. The results show that the QOL score was significantly reduced in the treatment group as compared to the placebo group. Table and graphical representation given in Table 22 and figure 13A and 13B.
Table 22: QOL (DASS 21) Assessment

Discussion:
Menopause is the time that marks the end of your menstrual cycles. It's diagnosed after you've gone 12 months without a menstrual period. Menopause can happen in your 40s or 50s, but the average age is 51 in the United States and between 45 and 55 yr of age in India. Menopause is a natural biological process. But the physical symptoms, such as hot flashes, and emotional symptoms of menopause may disrupt your sleep, lower your energy or affect emotional health. There are many effective treatments available, from lifestyle adjustments to hormone therapy.
The goal of treatment was to reduce or eliminate the Menopause related mental health issues in females. Sponsor has developed the Menoveda Akira tablets containing the fixed dose of herbal ingredients, without preservatives and dyes. The tablets are easy to administer.
The primary end point change in pain Subject Global Assessment was evaluated on score of 0-3 from the baseline. Reduction in menopause related mental health issue calculated as SGA(Subject Global Assessment) score (0-3) which include anxiety, depression, insomnia, night sweats, hot flushes, tiredness, mood swings, Headache and memory loss.The mean of SGA- Anxiety score was 1.86 and 0.53 in the Treatment group whereas it was2.13 and 1.86 in the placebo group. The results show that the SGA- Anxiety score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- depression score was 1.66 and 0.56 in the Treatment group whereas it was1.8 and 1.66 in the placebo group. The results show that the SGA- Depression score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Insomnia score was 1.26 and 0.43 in the Treatment group whereas it was1.36 and 1.3 in the placebo group. The results show that the SGA-Insomnia score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Hot flushes score was 1.53 and 0.43 in the Treatment group whereas it was1.53 and 1.43 in the placebo group. The results show that the SGA-Hot flushes score was significantly reduced in the treatment group as compared to the placebo group.
The mean of SGA- Headache score was 1.3 and 0.36 in the Treatment group whereas it was 1.4 and 1.33 in the placebo group. The results show that the SGA-Headache score was
significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Memory loss score was 0.93 and 0.5 in the Treatment group whereas it was 0.93 and 0.93 in the placebo group. The results show that the SGA-Memory loss score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Nights sweats score was 1.26 and 0.3 in the Treatment group whereas it was 1.16 and 1.4 in the placebo group. The results show that the SGA-Night sweats score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Tiredness score was 1.46 and 0.86 in the Treatment group whereas it was 1.56 and 1.4 in the placebo group. The results show that the SGA-Tiredness score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Irritability score was 1.33 and 0.4 in the Treatment group whereas it was 1.33 and 1.33 in the placebo group. The results show that the SGA-irritability score was significantly reduced in the treatment group as compared to the placebo group.The mean of SGA- Mood swings score was 1.5 and 0.46 in the Treatment group whereas it was 1.53 and 1.46 in the placebo group. The results show that the SGA-Mood Swings score was significantly reduced in the treatment group as compared to the placebo group.
The mean MENQOL score were 78.16 and 45.43 in the Treatment group whereas it was 77.5 and 75.23 in the placebo group. The results show that the MENQOL score was significantly reduced in the treatment group as compared to the placebo group.The mean QOL (DASS 21) score were 34.63 and 15.63 in the Treatment group whereas it was 36.26 and 33.56 in the placebo group. The results show that the QOL (DASS 21) score was significantly reduced in the treatment group as compared to the placebo group.No adverse event was reported during the study.
The above disclosure is non-limiting and modifications and variations are possible without departing from the spirit and scope of the invention. Since other modifications and changes, varied to fit particular operating requirements and environments, are apparent to those skilled in the art, the invention is not considered limited to the example chosen for purposes of disclosure, and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.
Having thus described the invention, what is desired to be protected by Letters Patent is presented in appended claims.
, Claims:WE CLAIM:
1. a herbal tablet formulation to provide a better mental health, comprising ;
(a) herbs Rauvolfia serpentina 160-240 mg, Asparagus racemosus 80-120 mg ,Withania somnifera 80-120 mg, Centella asiatica 80-120 mg, Acorus calamus 40-60 mg ,Convolvulus prostrates 20-60 mg, Nigella sativa 30-70mg, Glycyrrhiza glabra Linn. 64-96mg, Tinospora cordifolia 64-96mg ,Adhatoda vasica 24-36mg, Nardostachys jatamansi DC 16-24mg,Quercus infectoria 40-60mg; as active pharmaceutical ingredient;
(b) Mukta pishti 80-120 mg ; and
(c) Gum Acacia100mg as binder .
2. The herbal tablet formulation as claimed in claim 1 wherein 1000mg tablet preferably comprises Rauvolfia serpentina 200 mg, Asparagus racemosus 100 mg ,Withania somnifera 100 mg, Centella asiatica 100 mg, Acorus calamus 50 mg ,Convolvulus prostrates 40 mg, Nigella sativa 50 mg, Glycyrrhiza glabra Linn. 80 mg, Tinospora cordifolia 80 mg ,Adhatoda vasica 30 mg, Nardostachys jatamansi DC 20 mg, Quercus infectoria 50 mg.
3. The herbal tablet formulation as claimed in claim 1 wherein 1000mg tablet preferably comprises 100 mg Mukta pishti .
4. The herbal tablet formulation as claimed in claim 1 wherein 1000mg tablet comprises 100 mg Gum Acacia as tablet binder .
5. The herbal tablet formulation as claimed in claim 1 wherein tablet formulation is prepared by a process comprising steps;
a. taking different raw herbs in preferred amount and check them for any impurity and foreign matters;
b. steam sterilizing the raw herbs for 15 to 20 minutes;
c. drying raw herbs by tray dryer for 1 hour;
d. grinding all herbs together in a grinder to make fine powder;
e. adding ground Mukta pishti to blend of step (d) and mix thoroughly in conical mixer;
f. passing herbal powder blend through rotary magnet and then passing through sieve no.100;
g. adding 100 mg Gum acacia(q.s) and 10% distilled water in above blend of step (f);
h. forcing wet mass by wet granulation with sieve no. 20;
i. drying wet granules in tray dryer at 600C temperature for 3-4 hrs;
j. dry sieving through 20 no. mesh;
k. punch through 55 station rotary tablet press machine to make tablets; and
l. using magnetic separator to check metal adulteration from tablet as part of quality check before packaging.
Dated this 29th day of August , 2023

Nalini Kant Pandey
(IN/PA 2187)
of Mitakshara IP Services
Agent(s) for applicant(s)