| CTRI Number |
CTRI/2024/09/073491 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the Effect of Samasaktu Sarpigudyog on Calf Muscle Strength in Kho-Kho Players |
|
Scientific Title of Study
|
Clinical evaluation of the effect of samasaktu sarpigudyog on calf muscles strength in kho-kho players |
| 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 Aarti Ashok Dumbre |
| Designation |
PG Student Ayurved Samhita and Siddhant Department |
| Affiliation |
Dr. G. D. Pol Foundation YMT Ayurvedic Medical College and Hospital PG Institute |
| Address |
Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India
Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9892399802 |
| Fax |
|
| Email |
dr.aarti.dumbre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mandar Karve |
| Designation |
Lecturer in Ayurved Samhita and Siddhant Department |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital PG Institute |
| Address |
Dr G D Pol Foundation
DR G D POL FOUNDATION YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India
Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9422552908 |
| Fax |
|
| Email |
mandarkarve81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti Ashok Dumbre |
| Designation |
PG Student Ayurved Samhita and Siddhant Department |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital PG Institute |
| Address |
Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India
Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
dr.aarti.dumbre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Aarti Ashok Dumbre |
| Address |
Dr G D Pol Foundation
YMT Ayurvedic Medical College and Hospital PG Institute
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India 410210 |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 Aarti Ashok Dumbre |
Dr G D Pol Foundation YMT Ayurvedic Medical College and Hospital PG Institute |
AYURVED SAMHITA AND SIDDHANT DEPARTMENT
Institutional Area Sector 4 Kharghar Navi Mumbai Maharashtra India 410210
Raigarh
MAHARASHTRA |
9892399802
dr.aarti.dumbre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yerala Medical Trust Ayurvedic Mahavidyalaya Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Above 18yrs age group
Below 35yrs age group |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Daily practice of kho kho game, Ritucarya: - , Acara Rasayana: - , Other:- , Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Samasaktu Sarpigudyog , Reference: Charak samhita , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Dugdha ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
kho-kho players those who are doing routine practice for minimum 1 year Individuals with Age limit is 18 to 35 years Individuals of Male Female and either gender will be included
|
|
| ExclusionCriteria |
| Details |
Individuals with Age below 18 and above 35 years Individuals having Diabetes Mellitus Type 1 and Type 2 Tuberculosis of any part Hypertension Anaemia Any Lung Disease Heart disease Any major illness or operated recently for any cause
•Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Calf muscle endurance is analysed on the basis of Standing Heel Rise test, Running test and questionary will be filled |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve Stamina, Strength |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="2"
Months="0"
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
|
Aim : Clinical evaluation of the effect of samasaktu sarpigudyog on calf muscles strength in kho-
kho players.
Objectives : Clinical evaluation of the effect of samasaktu sarpigudyog in endurance and
Performance Improvement.
Clinical evaluation of the effect of samasaktu sarpigudyog in generalised body pain.
Need of the Study : • It is an effort to increase their Calf muscles strength by using classical ayurvedic
Methods and test as currently there are not many effective therapies available for
this calf muscles strength.
Hence, Here we are conducting the study to evaluate the effect of ‘Samasaktu
Sarpigudyog’ on Calf muscles strength in kho-kho players.
Data generated will be subjected to statistical analysis. Interpretation with the help of detailed
discussion and conclusion will be drawn. |