| CTRI Number |
CTRI/2025/07/090430 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Harbal medicine on Athletic Performance |
|
Scientific Title of Study
|
Effect of Sharamahara Mahakashaya an Ayurvedic Supplement on Athletic Performance |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEKSHA RAI |
| Designation |
Ph.D. Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7985687545 |
| Fax |
|
| Email |
diksharai780@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sisir Mandal |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8697097984 |
| Fax |
|
| Email |
todrskmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. SISIR MANDAL |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU, Varanasi, Uttar Pradesh, India-221005
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU, Varanasi, Uttar Pradesh, India-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8697097984 |
| Fax |
|
| Email |
todrskmandal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University, Varanasi, Uttar Pradesh, India 221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Deeksha Rai |
Sir Sundar Lal Hospital |
Sir Sundar Lal Hospital, Vikriti Vigyan OPD, Room No. 24 Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India-221005
Varanasi
UTTAR PRADESH |
07985687545
diksharai780@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee IMS |
Approved |
| Institutional Ethical Committee IMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Athletes |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHRAMAHARA MAHAKASHYA, Reference: CHARAK SAMHITA SUTRA STHAAN 4TH CHAPTER, Route: Oral, Dosage Form: Khanda /Granules, Dose: 12(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Group | No Drug is given |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
State-level athletes from SAI, Varanasi Center.
Age groups ranged from 16 to 20 years.
Selected hematological, hepatic, and renal variables
|
|
| ExclusionCriteria |
| Details |
Athletes with medical and psychological issues will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Change in athletic cardiovascular endurance rating scale
2 Change in hematological renal and hepatic rating scale |
1 Change is assessed before and after gave 8 week of a herbal supplement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2: Change in hematological renal & hepatic rating scale |
2: This change will be assessed before & after an 8-week course of herbal supplement |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/07/2025 |
| 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="3"
Months="6"
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
|
This study is a two group (control and treatment) prospective interventional study to evaluate the effect of herbal supplements (Shramahara Mahakashaya) on athletic performance. The supplements are made from 6 fruits, 2 grains, stems, and seed kernels. The outcome may be a change in the athletic cardiovascular rating scale and an improvement in the performance of athletes. |