| CTRI Number |
CTRI/2025/10/096625 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of resin-based Ayurvedic formulations on physical and mental health of healthy population |
|
Scientific Title of Study
|
An open label, randomized, parallel, two arm [Resins] prospective clinical study of Herbo-mineral Ayurvedic formulation to evaluate the efficacy focusing on their impact on physical and mental health in healthy volunteers |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Kadhar |
| Designation |
Lecturer - Kayachikitsa |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
department of KAYACHIKITSA
10, Pipeline Road, R.P.C. Layout, Vijayanagar
Bangalore
KARNATAKA
560104
India |
| Phone |
9845199790 |
| Fax |
|
| Email |
abukaya2003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur India Limited |
| Address |
Medical Affairs and clinical research
1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site 4 Sahibabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
911203378606 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur India Limited |
| Address |
Medical Affairs and clinical research department
1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site4 Sahibabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
911203378606 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research and Development Centre, Dabur India limited, Plot no 22,Site 4, Sahibabad Ghaziabad UTTAR PRADESH201010 India |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
1st floor, Dabur Research and Development Centre, Dabur Indialimited, Plot no 22,Site 4, Sahibabad Ghaziabad UTTAR PRADESH201010 India |
| Type of Sponsor |
Other [Ayurvedic Healthcare] |
|
|
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 Abdul Kadhar |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College and Research Centre |
Department of Kayachikitsa, 10, Pipeline Road, R.P.C. Layout Vijayanagar, Bangalore-560104
Bangalore
KARNATAKA |
9845199790
abukaya2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AH and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human volunteer |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DRDC/2025/007, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: 100-120 luke warm water), Additional Information: -(2) Medicine Name: DRDC/2025/009, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: 100-120 luke warm water), Additional Information: at night, after food |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Male participants aged between 18-60 years having BMI less than 35 kg/m2.
2. Resting blood pressure averaging less than 140 by 90 mm/Hg.
3. Not on any medication for cardiovascular and metabolic disorders.
4. Willing to provide consent and come for follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1. Participants with any acute illness require immediate medical care.
2. Participants with any chronic medical condition.
3. Any other condition which proves participant unfit for the study participation.
4. Any known cardiovascular or metabolic disease.
5. Participants who are taking any other related supplementation.
6. 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in strength, power and energy [Balya] 2. Improvement in bone and muscle strength [Balya] (Bone profile basic non fasting examination – ALP, Calcium, serum phosphorus, Vitamin D, Zinc and Parathyroid).
3. Improvement in recovery from weakness [Rasayana] 4. Improvement in performance
5. Improvement in mental health [Medya] (stress, memory and cognition).
|
week 1 and week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in serum testosterone levels
2. Safety and tolerability
|
week 1 - visit 1
week 12 - visit 2 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Objective is to evaluate efficacy and
safety of Herbo-mineral Ayurvedic formulations focusing on
their impact on physical and mental health. Inclusion criteria: 1.
Male participants aged between 18-60 years
having BMI less than 35 kg/m2. 2. Resting blood pressure averaging less than
140 by 90 mm/Hg. 3. Not on any medication for cardiovascular
and metabolic disorders. 4) Willing
to provide consent and come for follow-up visits. Exclusion criteria: 1.
Participants with any acute illness require
immediate medical care. 2.
Participants with any chronic medical condition. 3.
Any other condition which proves
participant unfit for the study participation. 4. Any known cardiovascular or metabolic disease. 5.
Participants who are taking any other
related supplementation. 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. Primary outcomes: improvement in strength, stamina and energy.
|