| 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
|
|
|
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
|
|
|
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.
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