FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/081655 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial of interventional products in reducing stress and anxiety, and improving mood in adults. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel-arm clinical trial of interventional products in reducing stress and anxiety, and improving mood in adults. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/050 Version: 1.00 dated 28th Dec 2024  Protocol Number 
MHC/CT/24-25/050 Version: 2.00 dated 7th February 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Senior Consultant 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Fourth floor, OPD 401, 314 B, Telco Road, Chinchwad.

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G Balaji  
Designation  Scientist 
Affiliation  Mane Kancor Ingredients Pvt Ltd 
Address  Mane Kancor Ingredients Pvt Ltd, Angamaly.

Ernakulam
KERALA
683573
India 
Phone  9995803488  
Fax  -  
Email  Balaji.G@MANE.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sherena PA  
Designation  Senior Scientist  
Affiliation  Mane Kancor Ingredients Pvt Ltd 
Address  Mane Kancor Ingredients Pvt Ltd, Angamaly.

Ernakulam
KERALA
683573
India 
Phone  9995869736  
Fax  -  
Email  Sherena.PA@MANE.com  
 
Source of Monetary or Material Support  
Mane Kancor Ingredients Pvt. Ltd. Angamaly, Kerala 683573 
 
Primary Sponsor  
Name  Mane Kancor Ingredients Pvt. Ltd. 
Address  Angamaly, Kerala 683573 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dilip Kadam  Care Multispeciality Hospital   Kolte Arcade, Nagar Rd, Wagholi Pune-411027, Maharashtra, India
Pune
MAHARASHTRA 
7066115411
-
drdilipnkadam@gmail.com 
Dr Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Fourth floor, OPD 401, 314/B, Telco Road, Chinchwad.
Pune
MAHARASHTRA 
8087282022
-
ramshyam.research@gmail.com 
Dr Dnyanraj Chowdhary  Sangvi Multispeciality Hospital  Sr. No 71/1/2/189, City Survey No. 2387, Krushna Chowk, Krushna Nagar, New Sangvi, 411027
Pune
MAHARASHTRA 
9823217423
-
drdnyanraj.sangvihospital@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Care Multispeciality Hospital Institutional Ethics Committee  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispecialty Hospital  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 
Comparator Agent  Placebo 1  One placebo capsule orally twice daily after the meal for 60 days. 
Comparator Agent  Placebo 2  One placebo sachet orally, dissolved with 200 ml water after the meal before bedtime once daily for 60 days. 
Intervention  Treatment 1  One capsule orally twice daily after the meal for 60 days.  
Intervention  Treatment 2  One capsule orally twice daily after the meal for 60 days. 
Intervention  Treatment 3  One sachet orally, dissolved with 200 ml water after the meal before bedtime daily for 60 days. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Participants meeting all the following criteria will be eligible for the study.
1. Male and female participants aged 21 to 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 that is 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 Alzheimers Disease Acquired Immuno Deficiency 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 110mm 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   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The efficacy endpoints of the study include assessment of
1. Changes in perceived stress scale (PSS) score at screening, day 15, day 30 and day 60.
2. Changes in serum cortisol levels at screening, day 30 and day 60.
3. Changes in Hamilton Anxiety Rating Scale (HAM-A) score at screening, day 30 and day 60.
4. Changes in COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score at screening, day 30 and day 60.
5. Changes in STAI (State-Trait Anxiety Inventory) score at screening, day 30 and day 60.
6. Changes in Profile of Mood State (POMS) questionnaire score (a. Total
Mood Disturbance b. Depression) at screening, day 15, day 30 and day
60.
7. Changes in visual analogue scale score- for evaluation of fatigue,
nausea, palpitation, breathlessness at screening, day 30 and day 60.
8. Changes in Modified Sleep Regularity and Medication Withdrawal Questionnaire (MSRMWQ)  
Screening, day 15, day 30 and day 60. 
 
Secondary Outcome  
Outcome  TimePoints 
The safety endpoints of our study include assessment of
1. Adverse events at baseline, day 15, day 30, and day 60.
2. Changes in hematological and biochemical parameters like complete blood count, liver function test and kidney function test at screening and day 60.
3. Assessment of treatment compliance and tolerability of investigational products at day 30 and day 60.
4. Changes in vital signs at screening, baseline, day 15, day 30, and day 60.
 
Screening, baseline, day 15 , day 30 and day 60 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "154"
Final Enrollment numbers achieved (India)="154" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/03/2025 
Date of Study Completion (India) 05/06/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Stress responses are crucial for survival, enabling us to adapt to challenging situations. However, chronic stress can have detrimental effects on both physical and mental health. It is a significant public health concern, contributing to a wide range of health issues. Studies suggest that stress-related disorders are responsible for a substantial portion of primary care physician visits, estimated to be between 75% and 90% .

 In today’s world, individuals are constantly exposed to stressors, making it difficult to avoid the impact of chronic stress. This increased exposure contributes to the rising incidence of stressrelated disorders such as depression, anxiety, and various neurodegenerative diseases. A systematic review conducted an integrative analysis of longitudinal and cross-sectional studies, revealing an inverse association between stress and quality of life. Furthermore, a separate review investigated the consequences of psychological stress on the aging process, concluding that it may impede healthy aging. Individuals with mental health diagnoses may experience stigma and social discomfort, leading to decreased help-seeking behaviours. This manifests as avoidance of healthcare professionals, staff, and service users. Additionally, it can hinder disclosure of information, limit question-asking and responding, and discourage complaints. 

Non-adherence to prescribed medications, particularly in public settings like educational institutions (colleges) and workplaces, presents a significant challenge. Research has been continuing to find a better alternative. This calls for the need to develop newer therapeutic strategies. Despite advancements in therapies and medications, achieving optimal treatment outcomes for stress-related conditions remains a challenge. Limited access to and high cost of psychotropic medications for patients continues to be a significant barrier to effective treatment. Therefore, exploring strategies to modulate an individual’s stress response is crucial. Plant extracts offer a promising avenue for mitigating the detrimental effects of stress, potentially serving as complementary or alternative approaches to existing medications and therapies.

 Investigational products containing ingredients like Rosemary (Rosemarinic acid and carnosic acid) and Ashwagandha (Withanolide aglycone and Withanolide glycosides) have the potential to calm the mind, reduce brain hyperactivity, and improve mood and anxiety. Rosemary and Ashwagandha possess well-documented ethnopharmacological and preclinical evidence supporting their potential anxiolytic, mood-enhancing, and cognitive-enhancing effects. Rosemary has demonstrated promising clinical effects on mood, learning, memory, pain, anxiety, and sleep. Ashwagandha, a renowned adaptogen, boasts a rich historical tradition and a wide array of purported health benefits, including stress reduction.

 Given their individual and potentially synergistic mechanisms of action, a combination of these botanical agents may offer a more comprehensive and effective approach to mitigating stress,anxiety, and associated symptoms. While promising preclinical and limited clinical data exist, further rigorous investigations are warranted to establish the efficacy and safety of this botanical combination in managing stress, anxiety, and improving mood in adult populations.
 
 
Close