| CTRI Number |
CTRI/2024/09/073264 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Herbal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Effectiveness and Safety of Mentacalm Tablets for Reducing Stress and Anxiety in Adults |
|
Scientific Title of Study
|
A single-arm clinical trial to evaluate the safety and efficacy of Mentacalm tablets in reducing stress and anxiety in adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/025 Version: 1.00 dated 16 July 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V G Vaidya |
| Designation |
Managing Trustee |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Forth floor OPD 401 314 B Telco Road Chinchwad
Pune MAHARASHTRA 411033 India |
| Phone |
9822057766 |
| Fax |
- |
| Email |
vgvclinical@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandip Mali |
| Designation |
Senior Manager – Medico-marketing |
| Affiliation |
Charak Pharma Pvt. Ltd |
| Address |
501 A, BUILDING-2, POONAM CHAMBERS, Dr Annie Besant Rd, Markandeshwar Nagar, Shiv Sagar Estate, Worli
Mumbai MAHARASHTRA 400018 India |
| Phone |
9702913695 |
| Fax |
- |
| Email |
drsandeepmali@charak.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sandip Mali |
| Designation |
Senior Manager – Medico-marketing |
| Affiliation |
Charak Pharma Pvt. Ltd |
| Address |
501 A, BUILDING-2, POONAM CHAMBERS, Dr Annie Besant Rd, Markandeshwar Nagar, Shiv Sagar Estate, Worli
MAHARASHTRA 400018 India |
| Phone |
9702913695 |
| Fax |
- |
| Email |
drsandeepmali@charak.com |
|
|
Source of Monetary or Material Support
|
| Vedistry Pvt. Ltd.
Evergreen Industrial Estate, Off E Moses Road, Mahalaxmi, Mumbai 400011.
|
|
|
Primary Sponsor
|
| Name |
Vedistry Pvt. Ltd. |
| Address |
Evergreen Industrial Estate, Off E Moses Road, Mahalaxmi, Mumbai 400011. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V G Vaidya |
Lokmanya Medical Research Centre |
Fourth-Floor OPD 401-314 B Telco Road Chinchwad Pune. Pune MAHARASHTRA |
9822057766 - vgvclinical@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z733||Stress, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mentacalm Tablet |
one Mentacalm tablet two times in a day after food orally. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female participants aged 21-50 years (both inclusive);
2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26;
3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form;
4.No severe anxiety and depression i.e, Generalized anxiety disorder (GAD) score less than or equal to 10 and Patients’ health questionnaire-9 (PHQ-9) score less than or equal to 14;
5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period;
6.No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial);
7.Willing to limit caffeine consumption while in the study.
|
|
| ExclusionCriteria |
| Details |
1.Inability to perform any of the assessments required for endpoint analysis;
2.Shows signs of dementia, such as caused by Alzheimer’s Disease, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH);
3.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management;
4.Have any other neurodegenerative diseases or seizure disorder;
5.Known hypersensitivity to investigational products;
6.Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy;
7.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study;
8.Sitting or resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening;
9.Participants with a history of substance abuse, drugs, heavy use of alcohol, and or smoking within last 5 years;
10.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The efficacy endpoints of the study include assessment of:
1.Changes in Perceived stress scale (PSS) score at screening, day 30 and day 60.
2.Changes in Serum cortisol levels at screening, day 30 and day 60.
3.Changes in Depression anxiety stress scale (DASS) at screening, day 30 and day 60.
4.Changes in Hamilton anxiety rating scale (HAM-A) score at screening, day 30 and day 60.
5.Changes in Penn state worry questionnaire (PSWQ) score at screening, day 30 and day 60.
6.Changes in Profile of mood state (POMS) questionnaire score at screening, day 30 and day 60.
7.Changes in World health organization quality of life questionnaire (WHOQOL-BREF) score at screening, day 30 and day 60.
8.Changes in Modified Sleep Regularity and Medication Withdrawal Questionnaire (MSRMWQ) score after stopping treatment for 1 week (day 68).
|
screening, day 30, day 60 and day 68
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of adverse events from baseline to end of the study.
2.Assessment of treatment compliance and tolerability of investigational products throughout the study.
3.Assessment of changes in vital sign parameters throughout the study.
4.Assessment of changes in physical examination such as weight, blood pressure and pulse at screening and end of the study.
5.Assessment of changes in complete blood count, liver function test and renal function test at screening and end of the study.
|
screening, day 30 and day 60. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/09/2024 |
| Date of Study Completion (India) |
24/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stress, a significant psychosocial stressor, is a primary
contributor to the pathogenesis of various mental health disorders, including
anxiety and depression. Its deleterious effects extends beyond emotional
distress, impairing cognitive function, such as concentration and
decision-making. The intricate relationship between stress, mental health, and
cognitive function underscores the necessity for effective stress management
strategies to mitigate these detrimental consequences and promote overall well-being.
Moreover, the potential interplay between stress, nutrition, and cognitive
health necessitates a comprehensive approach to address these interconnected
factors. The prevalence of stress and anxiety has significantly increased in
recent years, with approximately one-third of the population reporting symptoms. Mood and anxiety disorders, encompassing stress, anxiety, and depression,
constitute a significant public health burden . Systematic reviews of
longitudinal and cross-sectional data consistently demonstrate an inverse
relationship between stress and quality of life. Additionally, research
indicates that chronic psychological stress may accelerate the aging process. Pharmacological interventions are indicated for severe mental health conditions,
while milder presentations often benefit from a multimodal approach integrating
nutraceuticals and cognitive-behavioral therapy (CBT). This holistic strategy
optimizes outcomes while mitigating the economic burden associated with
psychotropic medications and overcome significant barriers to care.
Individuals with mental health diagnoses often encounter
significant stigma and social discrimination, leading to reduced help-seeking
behaviours. This manifests in avoidance of healthcare settings and limited
engagement with mental health professionals, hindering therapeutic alliance and
information disclosure. Non-adherence to prescribed psychotropic medications,
particularly within public and academic environments, is a prevalent challenge.
These factors underscore the urgent need for innovative therapeutic strategies
to address the multifaceted barriers to mental health care. The convenience and
established efficacy of traditional tablet formulations offer distinct
advantages for medication adherence. Tablets provide a reliable and consistent
method of drug delivery, contributing to optimal therapeutic outcomes.
Mentacalm tablet containing ingredients which have the potential to calm the
mind, reduce brain hyperactivity, and improve mood and anxiety. Within this
compendium of noteworthy botanical agents, Bacopa monnieri and Convolvulus
prostrates stands out as an herb with an extensive historical tradition and a
multitude of purported health benefits, in the investigational product along
with Withania somnifera, Celastrus paniculatus, Acorus calamus, Terminalia
arjuna, Valeriana wallichii it could synergistically add potential to mitigate
stress and related symptoms in a better way. While these ingredients show
promise in preliminary research, further studies are needed to confirm their
effectiveness at the dosages typically found in tablets. The current research aims at evaluating safety and efficacy of
Mentacalm in management of stress and anxiety in adults. |