| CTRI Number |
CTRI/2024/05/067009 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Mashadi Modaka granules as nutritional supplement in healthy sports persons |
|
Scientific Title of Study
|
Efficacy of Mashadi Modaka granules as nutritional supplement in healthy sports persons: A Randomized Controlled 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 |
Vd Supriya Chabukswar |
| Designation |
MD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta Room no 524 fifth floor Institute Building Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
8329010394 |
| Fax |
|
| Email |
drsupriyachabukswar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalinee Kumari Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Swasthavritta Room no 524 fifth floor Institute Building Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9664540469 |
| Fax |
|
| Email |
drshalinee@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalinee Kumari Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Swasthavritta Room no 524 fifth floor Institute Building Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9664540469 |
| Fax |
|
| Email |
drshalinee@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat, India 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Opp to Reliance Smart Near B Division Police Station Jamnagar Gujarat |
| 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 Supriya Chabukswar |
ITRA |
Room no. 7, OPD No. 12, Department of Swasthavritta and Yoga, UG Campus Hospital, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar
GUJARAT |
8329010394
drsupriyachabukswar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Institute of Teaching and Research in Ayurveda (INI), Jamnagar, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Active Sports Persons |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mashadi Modaka granules , Reference: Sharangadhar Samhita madhyam khanda chapter 7 verse 101-105, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Cow Milk), Additional Information: Apathya- Kshara & Amla 2. Granule form of Mashadi Modaka is selected for the research work | | 2 | Comparator Arm (Non Ayurveda) | | - | Normal daily diet | healthy sports person only on a routine daily diet without any additional nutritional supplements for 30 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing healthy sports persons between 18-35 years of age.
2.Only trained, daily active sports persons competing in district level competitions shall be selected.
3.Sports person who has not visited hospital in last 3 months for any illness.
4.Sports person who has not taken any other performance enhancing drug simultaneously.
5.Sports person who has not taken medications for any chronic illness.
6.Sports person having Fitness Quotient score ≥101. |
|
| ExclusionCriteria |
| Details |
1.Below 18 and above 35 years of age.
2.In the patients of serious metabolic illness.
3.Sports person taking any medication or steroids to enhance physical performance.
4.Sports person having drug abuse history.
5.Any other conditions which the investigator judge problematic for participation in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mashadi Modaka granules is effective in healthy sports persons assessing the nutritional status by general examination, physical test and laboratorial investigations. |
30 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional improvement in sports persons. |
30 DAYS |
| Improvement in quality of life of sports persons. |
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
03/06/2024 |
| 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="1"
Months="10"
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
|
Due to inadequate requirement of nutritional supplement sports persons suffer from syndrome named as Relative Energy Deficiency in Sports (RED-S). Mashadi Modaka has an effective as Pushti as per Sharangdhar Samhita and due to having multi-ingredients, it acts as Brimhana, Santarpana, Pushti and Prinana. In study, total 30 healthy sports persons from DKV arts and Commerce College, Jamnagar, Gujarat, if necessary nearby Colleges will be enrolled voluntarily. In first group of healthy sports persons (Group MN) Mashadi Modaka Granules will be given 10 gms orally twice a day empty stomach for 30 days without changing routine diet pattern and in Group N (15 healthy sports persons) will be only on routine daily diet without any additional nutritional supplement. Aim: To evaluate the efficacy of Mashadi Modaka Granules as nutritional supplement in healthy sports persons. Objective: 1.To compile and critically evaluate the aspect of nutrition in the sports in ancient and modern literature. 2. To evaluate the improvement in quality of life in sports person. |