CTRI

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CTRI Number

CTRI/2025/12/098275 [Registered on: 01/12/2025] Trial Registered Prospectively

Last Modified On:

30/10/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Other (Specify) [Marma Therapy]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Assessment of Srama (Muscle fatigue) and its Management with Marma therapy and Sramahara Mahakashaya in Athletes

Scientific Title of Study

An Open Labelled Randomised Clinical Trial to Evaluate the Effectiveness of Marma Therapy and Sramahara Mahakasaya in Relieving Srama (Muscle fatigue) by Assessing Muscle Strength and Endurance in Athletes.

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 LAKSHMY DEVI K
Designation	Ph D Scholar
Affiliation	NATIONAL INSTITUTE OF AYURVEDA (DU)
Address	DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD JAIPUR DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD Jaipur RAJASTHAN 302002 India
Phone	9446074008
Fax
Email	drlakshmydevimanoj008nia@gmail.com

Details of Contact Person
Scientific Query

Name	PROF (Dr) SUNIL KUMAR YADAV
Designation	H O D
Affiliation	NATIONAL INSTITUTE OF AYURVEDA (DU)
Address	DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD JAIPUR DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD JAIPUR Jaipur RAJASTHAN 302002 India
Phone	9413181445
Fax
Email	drskyadav4@gmail.com

Details of Contact Person
Public Query

Name	Dr LAKSHMY DEVI K
Designation	Ph.D. SCHOLAR
Affiliation	NATIONAL INSTITUTE OF AYURVEDA (DU)
Address	DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD JAIPUR DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD Jaipur RAJASTHAN 302002 India
Phone	9446074008
Fax
Email	drlakshmydevimanoj008nia@gmail.com

Source of Monetary or Material Support

NATIONAL INSTITUTE OF AYURVEDA (DU)

Primary Sponsor

Name	NATIONAL INSTITUTE OF AYURVEDA
Address	NATIONAL INSTITUTE OF AYURVEDA(DU) JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN-302002
Type of Sponsor	Other [INSTITUTE]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr LAKSHMY DEVI K	NATIONAL INSTITUTE of AYURVEDA JAIPUR	DEPARTMENT OF RACHANA SHARIRA NATIONAL INSTITUTE OF AYURVEDA (DU) JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN-302002 Jaipur RAJASTHAN	9446074008 drlakshmydevimanoj008nia@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF AYURVEDA	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Shrama (Muscle Fatigue) after physical activity

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Shramahara Mahakashaya, Reference: Caraka Sutrasthana 4/16, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2	Intervention Arm	Procedure	-	marmacikitsA, मर्मचिकित्सा	(Procedure Reference: Marmachikitsa- Basic Tenets in Ayurveda and Therapeutic Approaches; CCRAS,2020; ISBN:97881- 943932-8-3., Procedure details: 17- 18 stimulations on each marma will be given for 0.8 sec each, in each sitting. 2 sittings a day for 14 days)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	The athletes who are willing to participate in the study after being provided with the details of this trial, understanding the details completely and willing to provide informed written consent will be registered. Athletes between 18 to 25 years of age. Both male and female Athletes. Athletes with 1 or more than 1 year in professional sport Athletes involved in 40 to 60 minutes of medium to intensive physical activity regularly.

ExclusionCriteria

Details

Athletes with any injuries.
Athletes suffering from any systemic diseases.
Athletes on other therapies.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Change in grading level of MFSI –SF Scale before and after treatment. Change in grading level of MMT Scale before and after treatment.	Reduction in fatigue at the end of 14 days.

Secondary Outcome

Outcome	TimePoints
Change in measurements of muscle strength as measured by the Dynamometer. Change in measurements of elapsed time as measured by the stopwatch (in seconds).	Change in Muscle strength and endurance at the end of 14 days.

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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

Date of First Enrollment (India)

01/12/2025

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="1"
Months="0"
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

Srama is stated as tiredness following excess physical work. Hence Muscle Strength and endurance are significant factors deciding performance in trained athletes. Herbal formulations like Sramahara Mahakasaya aids proper circulation of nutrition and it may be a potential option for athletes to alleviate the fatigue, which develops gradually soon after the onset of the sustained physical activity. Marma therapy facilitates a streamlined pathway to restore homeostasis and enhances overall vitality. Hence the study will be taken up including athletes, both male and female, between 18-25 years of age, with 1 or more years in professional sport and who are regularly involved in 40-60 minutes of medium to intensive physical activity. Athletes who are willing to participate in the study will be registered and made to fill the CSF. The study participants will be asked to fill in MFI-SF Questionnaire and MMT of Quadriceps and Hamstrings will be recorded and later the Blood test for BUN will be collected 0^th day and 15^th day after the trial. Similarly, Muscle strength using Dynamometer and muscle endurance will be tested. 30 athletes will be given Marma Therapy and 30 will be given Sramahara Mahakashaya for 14 days. The data obtained shall be analysed through statistical tests to find the effectiveness of Marma Therapy and Sramahara Mahakashaya in srama (muscle fatigue).