| CTRI Number |
CTRI/2025/03/081936 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Creating Brimhaniya Masha and Mudga Flour and Exploring Their Health Benefits for Gym Goers: A Randomized Study |
|
Scientific Title of Study
|
Development of Brimhaniya Masha and Mudga saktu and assessing its effects in Health of Gym Goers A Randomized Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoop Kumar |
| Designation |
PG SCHOLAR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Swasthavritta, All India Institute of Ayurveda,Mathura Road, Gautampuri, Sarita Vihar, New Delhi.
South
DELHI
110076
India |
| Phone |
9990878508 |
| Fax |
|
| Email |
anoopkmr157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDrMEDHA S KULKARNI |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.- 601, 6th floor, Academic Block, Department of
Swasthavritta, All India Institute of Ayurveda, Gautampuri, Mathura
Road, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9890355305 |
| Fax |
|
| Email |
medha63@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar S Harti |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No.- 602, 6th floor, Academic Block, Department of
Swasthavritta, All India Institute of Ayurveda, Gautampuri, Mathura
Road, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9611275434 |
| Fax |
|
| Email |
shivakumarsharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri, Mathura Road, Sarita Vihar, New Delhi-110076, India |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYUVEDA |
| Address |
Mathura Road, Gautampuri, Sarita Vihar, Delhi-110076, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anoop kumar |
ALL INDIA INSTITUTE OF AYURVEDA |
Room No.- 420, 4th
floor, Academic Block,
All India Institute of
Ayurveda, Gautampuri,
Mathura Road, Sarita
Vihar, New
Delhi-110076
South
DELHI |
9990878508
anoopkmr157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research & Biostatistics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | whey protein supplement 1 scoop ~ 30gm (25g protein) once a day in 1 glass of water/milk for a period of 45 days. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Developed brimhaniya Masha and mudga saktu - 2 scoops (13.4 gm protein) twice a day in 1 glass of water for a period 45 days., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Apparently healthy gym going volunteers, consuming protein supplements atleast for 3 months
or more than 3 months
2) Age – 18 - 50
3) Gender – Irrespective of gender.
4) Irrespective of skin color, class, or social group. |
|
| ExclusionCriteria |
| Details |
1) Individuals with any acute or chronic systemic illness.
2) Individuals with any pathology requiring consumption of nutritional supplements.
3) Individuals taking any types of steroids
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| significant effects in health parameters( LFT KFT, Testosterone, creatine kinase anthropometric measurements, BMI) of gym goers after taking different types of protein supplements and developed saktu |
effect after a period of 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant effects in health parametres of gym goers.
LFT, KFT ,Testosterone, Creatinine kinase, anthropometric measurements,
BMI |
45 days |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The synopsis details a clinical trial comparing the effects of an Ayurvedic protein supplement made from masha (black gram) and mudga (green gram) with whey protein on gym-goers over 45 days. The study evaluates health parameters such as liver and kidney function, muscle recovery, and overall fitness using the Swasthya Assessment Scale (SAS). The trial involves 400 participants and includes a survey to assess if the Ayurvedic supplement provides similar or better benefits than whey protein. Expected outcomes include improved muscle health, reduced fatigue, and better nutrient delivery. |