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Effect of Menoveda Akira Tablets on Females with Menopause related mental health issues Title -"A double blind

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Shikha Sharma
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Abstract

A double blind, randomized, placebo controlled Clinical Study to evaluate the efficacy of Menoveda Akira Tablets in patients having menopause related mental health issues. Material and Method- The study was done as per ICH GCP guidelines at Shree Ram Hospital Meerut with approval from the Institutional Ethics committee. The subjects were enrolled according to the inclusion and exclusion criteria, 60 female subjects in the ratio of 1:1 in each group with mean age 47.8 years in treatment group and 50.5 years in Placebo group. The analysis was done on efficacy factors collectively mentioned as SGA, along with Quality of life of Menopause related mental health issues and MENQOL. The assessments were done on day 0, 15th and day 30. Result- There was significant improvement in primary and secondary factor such as SGA(Subject Global Assessment) for Menopause related mental health issues which include the mean of SGA Anxiety score was 1.86 and 0.53 in the Treatment group whereas it was 2.13 and 1.86 in the placebo group before treatment and post treatment respectively. Similarly, The mean of SGA- depression score was 1.66 and 0.56 in the Treatment group whereas it was 1.8 and 1.66 in the placebo group. The mean of SGA- Insomnia score was 1.26, and 0.43in the Treatment group whereas it was1.36 and 1.3 in the placebo group. The mean of SGA- Hot flushes score was 1.53 and 0.43 in the Treatment group whereas it was 1.53 and 1.43 in 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 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 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 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 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 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 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 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. Conclusion- The study concluded that Menoveda Akira tablets significantly reduces all major Menopause related mental health issue factors- 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
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Effect of Menoveda Akira Tablets on Females with Menopause related
mental health issues
Nidhi Dixit1, Dr. Shikha Sharma2
1-Research scholar at Department of Pharmaceutical Technology, Meerut Institute of Engineering and
Technology, NH-58, Bypass Road, Meerut, U.P.-250005, India
2- Gynecologist Shree Ram Hospital NH-58, Delhi-Haridwar Highway, Partapur Bypass Rd, Meerut, Uttar
Pradesh 250103
Title - “A double blind, randomized, placebo controlled Clinical Study to evaluate the
efficacy of Menoveda Akira Tablets in patients having menopause related mental
health issues.”
Material and Method- The study was done as per ICH GCP guidelines at Shree Ram Hospital
Meerut with approval from the Institutional Ethics committee. The subjects were enrolled according to
the inclusion and exclusion criteria, 60 female subjects in the ratio of 1:1 in each group with mean age
47.8 years in treatment group and 50.5 years in Placebo group. The analysis was done on efficacy
factors collectively mentioned as SGA, along with Quality of life of Menopause related mental health
issues and MENQOL. The assessments were done on day 0, 15th and day 30.
Result- There was significant improvement in primary and secondary factor such as SGA(Subject
Global Assessment) for Menopause related mental health issues which include the mean of SGA-
Anxiety score was 1.86 and 0.53 in the Treatment group whereas it was 2.13 and 1.86 in the placebo
group before treatment and post treatment respectively. Similarly, The mean of SGA- depression score
was 1.66 and 0.56 in the Treatment group whereas it was 1.8 and 1.66 in the placebo group. The mean
of SGA- Insomnia score was 1.26, and 0.43in the Treatment group whereas it was1.36 and 1.3 in the
placebo group. The mean of SGA- Hot flushes score was 1.53 and 0.43 in the Treatment group
whereas it was 1.53 and 1.43 in 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 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 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 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 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 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 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 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.
Conclusion- The study concluded that Menoveda Akira tablets significantly reduces all major
Menopause related mental health issue factors- 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.
INTRODUCTION
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.[1]
Types of Menopauses:
There are three stages of menopause: perimenopause, menopause and post menopause.
Perimenopause is the time leading up to menopause. It describes a time when
hormones start to decline and menstrual cycles become erratic and irregular. You
may start to experience side effects of menopause, like hot flashes or vaginal
dryness.
Menopause occurs when you’ve stopped producing the hormones that cause your
menstrual period and have gone without a period for 12 months in a row. Once this
has occurred, you enter postmenopause.
Postmenopause is the time after menopause has occurred. Once this happens, you're
in postmenopause for the rest of your life. People in postmenopause are at an
increased risk for certain health conditions like osteoporosis and heart disease.[2]
The following symptoms of menopause are:
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
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 [2] as well as synthetic compounds such as Benzodiazepines like Diazepam,
Chlordiazepoxide, Alprazolam, Betablockers like Propranolol and H1 Antihistaminics like
Hydroxyzine, are used to treat anxiety.[3]
Large population-based surveys have shown that up to 33.7% of people will experience an
anxiety disorder at some point in their lives. These illnesses have been shown to be
significantly under diagnosed and undertreated. The prevalence rates of anxiety disorders
have not altered in recent years, according to the research. Prevalence rates in cross-cultural
comparisons vary greatly. This heterogeneity is more likely the result of methodological
variations than cultural effects. Although anxiety disorders have a chronic history, their
prevalence naturally declines as people get older. Anxiety disorders frequently co-occur with
various mental illnesses and other anxiety disorders. [4]
Menoveda Akira Tabletsis investigational product used for the Anxiety to determine the
efficacy. The syrup is manufactured by Menoveda life sciences llp which contain many active
ingredients like Mukta Pishti(white pearl) - It is widely used in the Hyperacidity, anxiety,
fever, burning sensation etc[5] , Rauvolfia serpentina - It has anti-stress, anti-aging and life
strengthening activities.[6] , Asparagus racemosus - Asparagus racemosus, a climbing
Ayurvedic plant, is known for its numerous activities such as hyperlipidemia, hypertension,
angina, dysmenorrhea, anxiety disorders etc .[7] , Withaniasomnifera -W. somnifera used in
various central nervous system (CNS) disorders, particularly its indication in epilepsy, stress
and neurodegenerative diseases such as Parkinson's and Alzheimer's disorders, etc .[8],
Centella asiatica - C. asiatica in Ayurveda include its use for cognitive properties as a brain
tonic, in the treatment of mental disorders, and as a memory-enhancing agent etc.[9], Acorus
calamus - It is used in metabolic and neurological disorders, such as anticonvulsant,
antidepressant, antihypertensive, anti-inflammatory etc.[10], Convolvulus prostratus -It has
various pharmacological activity including CNS depression, anxiolytic, tranquillizing,
insomnia, antidepressant, antistress, etc .[11], Nigella sativa - N. 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.[12], Yashtimadhu - Glycyrrhiza glabra have been employed clinically for their anti-
inflammatory, antiulcer expectorant, antimicrobial and anxiolytic activities.[13], Guduchi - T.
cordifolia in countering various disorders and usages as anti-oxidant, anti-hyperglycemic,
antihyperlipidemic, hepatoprotective, cardiovascular protective, neuroprotective,
osteoprotective, radioprotective, anti-anxiety, etc.[14] , Adhatodavasica - Traditionally it was
used for the treatment of various acute and chronic diseases and showed strong
pharmacological activity particularly for bronchial infections, cough, bacterial infections,
reproductive disorders, cardiac diseases and many more.[15], Jatamansi - It is used in
depression and anxiety related problems.[16], Qurecusinfectoria - The multiple biological
activities including anti-inflammatory, antibacterial, hepatoprotective, antidiabetic, anticancer,
gastroprotective, antioxidant, etc.[17]
Material and Methods:
The trial was carried out at Shree ram Hospital Meerut under the direction of Dr. Shikha
Sharma, and the product called Menoveda Akira tablet was provided by Menoveda
Lifesciences 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.
Study drug:
Menoveda Akira Tablets is manufactured by Araiya Wellness, Delhi which contains
ayurvedic ingredients like-
Sr.No.
Ingredients
1.
Mukta pishti(white pearl)
2.
Rauwolfia serpentine
3.
Asparagus racemosus
4.
Withania somnifera
5.
Centella asiatica
6.
Acorus calamus
7.
Convolvulus prostrates
8.
Nigella sativa
9.
Yashtimadhu
10.
Guduchi
11.
Adhatoda vasica
12.
Jatamansi
13.
Quercus infectoria
The subjects will consume 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 Menoveda Akira 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 will be enrolled at 1 investigative site in India. Approximately 60 subjects who
meet the trial entry criteria will be randomly assigned in a 1:1 ratio to receive either
Menoveda Akira Tablets or Placebo tablet. The subjects will consume tablet orally twice a
day and for the duration of 30 days.
The maximum duration of the trial for each subject will be 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 will return 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.
S. No
Variable
Number of subjects
1.
No. of subjects screened for study
66
2.
No. of subject’s screen failure
6
3.
Reason for screen failure
Using Immunosuppressive
3
Not willing to sign ICF
3
4.
No. of subjects enrolled in the study
60
5.
Number of subjects completed the Study
60
Table 1: Patient disposition details
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.
S. No.
Variable
Test Product-
Menoveda Akira
tablets(N=30)
Placebo (N=30)
1.
Mean
47.8
50.5
Min
45
45
Max
54
55
2.
Mean
161.66
159.26
Min
151
151
Max
169
167
3.
Mean
65.3
76
Min
40
55
Max
100
97
4.
Mean
24.90
30.11
Min
16.83
21.2
Max
35.86
39.4
Table 2: Demographic characteristics
Efficacy Evaluations
Data sets Analyzed. Data from all 60 patients who completed the study were analyzed.
Table 3: Data sets analyzed
Treatments
Menoveda Akira tablets or Matching Placebo
Total screened
66
Enrolled
60
No. of patients completed
60
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 4 and figure 1)
SGA-Anxiety
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.86
0.53
2.13
1.86
Std deviation:
0.77
0.57
0.77
0.77
Std error:
0.14
0.10
0.14
0.14
Minimum:
0.0
0.0
0.0
0.0
Maximum:
3.0
2.0
3.0
3.0
Median:
2.0
0.5
<0.0001
2.0
2.0
<0.1885
Table 4: SGA- Anxiety Assessment
Figure 1: Graphical representation of Anxiety score for Test (A) and Placebo (B)
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 5 and figure 2)
SGA-Depression
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.66
0.56
1.8
1.66
Std deviation:
0.66
0.50
0.55
0.60
Std error:
0.12
0.09
0.10
0.11
Minimum:
0.0
0.0
0.0
0.0
Maximum:
3.0
1.0
2.0
2.0
Median:
2.0
1.0
<0.0001
2.0
2.0
<0.3764
Table 5: SGA- Depression Assessment
Figure 2: Graphical representation of Depression score for Test (A) and Placebo (B)
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 6 and figure 3)
SGA-Insomnia
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.26
0.43
1.36
1.3
Std deviation:
0.69
0.67
0.80
0.79
Std error:
0.12
0.12
0.147
0.145
Minimum:
0.0
0.0
0.0
0.0
Maximum:
2.0
2.0
2.0
2.0
Median:
1.0
0.0
<0.0001
2.0
1.5
<0.748
Table 6:SGA- Insomnia Assessment
Figure 3: Graphical representation of Insomnia score for Test (A) and Placebo (B)
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 7 and figure 4).
SGA-Hot flashes
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.53
0.43
1.53
1.43
Std deviation:
0.68
0.50
0.899
0.897
Std error:
0.12
0.09
0.164
0.163
Minimum:
0.0
0.0
0.0
0.0
Maximum:
3.0
1.0
3.0
3.0
Median:
2.0
0.0
<0.0001
2.0
1.5
<0.668
Table 7: SGA- Hot flashes Assessment
Figure 4: Graphical representation of Hot flushes score for Test (A) and Placebo (B)
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 8 and figure 5).
SGA-Headache
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.3
0.36
1.4
1.33
Std deviation:
0.53
0.49
0.56
0.54
Std error:
0.09
0.08
0.10
0.09
Minimum:
0.0
0.0
0.0
0.0
Maximum:
2.0
1.0
2.0
2.0
Median:
1.0
0.0
<0.0001
1.0
1.0
<0.643
Table 8: SGA- Headache Assessment
Figure 5: Graphical representation of Headache score for Test (A) and Placebo (B)
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 9 and figure 6).
SGA-Memory loss
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
0.93
0.5
0.93
0.93
Std deviation:
0.69
0.57
0.73
0.73
Std error:
0.12
0.10
0.135
0.135
Minimum:
0.0
0.0
0.0
0.0
Maximum:
2.0
2.0
2.0
2.0
Median:
1.0
0.0
<0.0001
1.0
1.0
<0.999
Table 9: SGA- Memory loss Assessment
Figure 6: Graphical representation of Memory loss score for Test (A) and Placebo (B)
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
given in (Table 10 and figure 7).
SGA-Night sweats
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.26
0.3
1.16
1.4
Std deviation:
0.63
0.46
0.69
0.67
Std error:
0.11
0.08
0.127
0.123
Minimum:
0.0
0.0
0.0
0.0
Maximum:
2.0
1.0
2.0
2.0
Median:
1.0
0.0
<0.0001
1.0
1.5
<0.1935
Table 10: SGA- Night sweat Assessment
Figure 7: Graphical representation of Night sweat score for Test (A) and Placebo (B)
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 11 and figure 8).
SGA-Tiredness
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.46
0.86
1.56
1.4
Std deviation:
0.73
0.62
0.77
0.77
Std error:
0.13
0.11
0.14
0.14
Minimum:
0.0
0.0
0.0
0.0
Maximum:
3.0
2.0
3.0
3.0
Median:
1.0
1.0
<0.0012
2.0
1.0
<0.4065
Table 11: SGA- Tiredness Assessment
Figure 8: Graphical representation of Tiredness score for Test (A) and Placebo (B)
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 12 and figure 9).
SGA-Irritability
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.33
0.4
1.33
1.33
Std deviation:
0.71
0.56
0.84
0.84
Std error:
0.12
0.10
0.15
0.15
Minimum:
0.0
0.0
0.0
0.0
Maximum:
3.0
2.0
3.0
3.0
Median:
1.0
0.0
<0.0001
1.0
2.0
<0.9999
Table 12: SGA- Irritability Assessment
Figure 9: Graphical representation of Irritability score for Test (A) and Placebo (B)
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 13 and figure 10).
SGA-Mood
swings score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
1.5
0.46
1.53
1.46
Std deviation:
0.86
0.50
0.81
0.73
Std error:
0.15
0.09
0.14
0.13
Minimum:
0.0
0.0
0.0
0.0
Maximum:
3.0
1.0
3.0
3.0
Median:
1.0
0.0
<0.0001
1.0
1.0
<0.7406
Table 13: SGA- Mood swing Assessment
Figure 10: Graphical representation of Mood swing score for Test (A) and Placebo (B)
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
14 and figure 11).
MENQOL score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
78.16
45.43
77.5
75.23
Std deviation:
17.80
12.06
22.86
21.06
Std error:
3.25
2.20
4.17
3.84
Minimum:
43.0
30.0
40.0
39.0
Maximum:
113.0
75.0
123
114
Median:
80.0
43.0
<0.0001
77.0
73.50
<0.6912
Table 14: MENQOL Assessment
Figure 11: Graphical representation of MENQOL score for Test (A) and Placebo (B)
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 15 and
figure 12).
QOL (DASS 21)
score
Menoveda Akira tablets
P value
Placebo
P value
Mean:
34.63
15.63
36.26
33.56
Std deviation:
9.37
4.64
8.59
8.88
Std error:
1.71
0.84
1.56
1.62
Minimum:
21.0
8.0
21.0
19.0
Maximum:
50.0
25.0
50.0
55.0
Median:
35.50
14.50
<0.0001
36.0
33.0
<0.2365
Table 15: QOL (DASS 21) Assessment
Figure 12: Graphical representation of QOL (DASS 21) score for Test (A) and Placebo (B)
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.
Conclusion:
In conclusion, the Menoveda Akira Tablets were significantly effective in maintaining
mental health. “A significant reduction was observed in assessment parameters with the
comparative results of the final visit”. There was significant improvement in the SGA,
MENQOL showing the efficacy of the Menoveda Akira Tablets in females having
menopause related mental health issues. Safety assessment and other vital signs results
confirmed that the product is safe. Considering the overall, score reduction, along with QOL
(DASS-21) and vital assessments, we can conclude that the Menoveda Akira Tablets is an
effective treatment for menopause related mental health issues which includes anxiety,
depression, insomnia, night sweats, hot flushes, tiredness, and mood swings.
Declaration of Conflicting Interests: The authors declared no potential conflicts of
interest with respect to the research, authorship, and/or publication of this article.
REFERENCES:
1. Anneliese Schwenkhagen, MD, Hormonal Changes in Menopause and Implications on Sexual
Health, The Journal of Sexual Medicine, Volume 4, Issue Supplement_3, March 2007, Pages
220–226, https://doi.org/10.1111/j.1743-6109.2007.00448.x
2. Motti, Riccardo, and Bruna de Falco. "Traditional herbal remedies used for managing
anxiety and insomnia in Italy: An ethnopharmacological overview." Horticulturae 7,
no. 12 (2021): 523.
3. Banerjee, Indrajit, Bedanta Roy, Brijesh Sathian, Indraneel Banerjee, Sai Sailesh
Kumar, and Archana Saha. "Medications for anxiety: a drug utilization study in
psychiatry inpatients from a tertiary care centre of Western Nepal." Nepal Journal of
Epidemiology 1, no. 4 (2011): 119-125.
4. Bandelow, Borwin, and Sophie Michaelis. "Epidemiology of anxiety disorders in the
21st century." Dialogues in clinical neuroscience (2022).
5. Thakre, Roshan, Mayur Barve, Sanjay Khedekar, and Pandit Sawant. "A review of
Mukta: An Ancient drug in Rasa Shastra." Journal of Ayurveda and Integrated
Medical Sciences 2, no. 02 (2017): 160-164.
6. Rajendran, A., R. Sudeshraj, and S. Sureshkumar. "Phytonutrients: Stress and
relaxation dietary health food supplements." The Pharma Innovation Journal 8, no. 5
(2019): 799-802.
7. Singla, Ramit, and Vikas Jaitak. "SHATAVARI (ASPARAGUS RACEMOSUS
WILD): A REVIEW ON ITS CULTIVATION, MORPHOLOGY,
PHYTOCHEMISTRY AND PHARMACOLOGICAL IMPORTANCE." International
Journal of Pharmacy & Life Sciences 5, no. 3 (2014).
8. Gopal, Sriram, Ashutosh Ajgaonkar, Padmaja Kanchi, Aditi Kaundinya, Vaishali
Thakare, Sanjaya Chauhan, and Deepak Langade. "Effect of an ashwagandha
(WithaniaSomnifera) root extract on climacteric symptoms in women during
perimenopause: A randomized, double‐blind, placebo‐controlled study." Journal of
Obstetrics and Gynaecology Research 47, no. 12 (2021): 4414-4425.
9. Puttarak, Panupong, PiyamethDilokthornsakul, SurasakSaokaew,
TeeraponDhippayom, ChuenjidKongkaew, RosarinSruamsiri, Anchalee Chuthaputti,
and NathornChaiyakunapruk. "Effects of Centella asiatica (L.) Urb. on cognitive
function and mood related outcomes: A Systematic Review and Meta-
analysis." Scientific reports 7, no. 1 (2017): 10646.
10. Sharma, Vineet, Rohit Sharma, DevNath Singh Gautam, Kamil Kuca, Eugenie
Nepovimova, and Natália Martins. "Role of Vacha (Acorus calamus Linn.) in
neurological and metabolic disorders: evidence from ethnopharmacology,
phytochemistry, pharmacology and clinical study." Journal of clinical medicine 9, no.
4 (2020): 1176.
11. Agarwa, Parul, Bhawna Sharma, Amreen Fatima, and Sanjay Kumar Jain. "An update
on Ayurvedic herb Convolvulus pluricaulis Choisy." Asian Pacific journal of tropical
biomedicine 4, no. 3 (2014): 245-252.
12. Alenazi, Shehab Ahmed. "Neuropsychiatric effects of Nigella sativa (black seed) A
review." Alternative & Integrative Medicine (2016).
13. Dhingra, Dinesh, Milind Parle, and S. K. Kulkarni. "Memory enhancing activity of
Glycyrrhiza glabra in mice." Journal of ethnopharmacology 91, no. 2-3 (2004): 361-
365.
14. Dhama, Kuldeep, Swati Sachan, Rekha Khandia, Ashok Munjal, Hafiz MN Iqbal,
Shyma K Latheef, Kumaragurubaran Karthik, Hari A Samad, Ruchi Tiwari, and
Maryam Dadar. "Medicinal and beneficial health applications of Tinospora cordifolia
(Guduchi): a miraculous herb countering various diseases/disorders and its
immunomodulatory effects." Recent patents on endocrine, metabolic & immune drug
discovery 10, no. 2 (2016): 96-111.
15. Shoaib, Ambreen. "A systematic ethnobotanical review of Adhatodavasica (L.),
Nees." Cellular and Molecular Biology 67, no. 4 (2021): 248-263.
16. Mude, Gaurav, Shailesh Pise, Kanchan Makade, Rajshree Fating, and Seema
Wakodkar. "Potentiating effect of N. Jatamansi root extract by evaluating anti-
depression and anxiolytic activity in rats." Journal of Pharmacognosy and
Phytochemistry 9, no. 3 (2020): 1734-1738.
17. Taib, Mehdi, Yassine Rezzak, LahboubBouyazza, and BadiaaLyoussi. "Medicinal
uses, phytochemistry, and pharmacological activities of Quercus species." Evidence-
Based Complementary and Alternative Medicine 2020 (2020).
ResearchGate has not been able to resolve any citations for this publication.
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A systematic ethnobotanical review of Adhatoda vasica (L.), Nees
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