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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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