CTRI

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CTRI Number

CTRI/2025/09/094430 [Registered on: 09/09/2025] Trial Registered Prospectively

Last Modified On:

08/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Non-randomized, Multiple Arm Trial

Public Title of Study

A Comparative Study The Effect Of Madhudaka And Triyushnadi Mantha In The Management Of Atisthoulya (Obesity)

Scientific Title of Study

An Exploratory Study To Compare The Effect Of Madhudaka And Triyushnadi Mantha In The Management Of Atisthoulya (Obesity)

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 SAURABH AGARWAL
Designation	ASSOCIATE PROFESSOR
Affiliation	PGIA JODHPUR
Address	ROOM NO 104 DEPARTMENT OF SWASTHVRITTA AND YOGA POST GRADUATE INSTITUTE OF AYURVEDA JODHPUR ROOM NO 8 DEPARTMENT OF SWASTHVRITTA AND YOGA SANJIVANI HOSPITAL JODHPUR Jodhpur RAJASTHAN 342015 India
Phone	9972143436
Fax
Email	Drsaurabh101@gmai.com

Details of Contact Person
Scientific Query

Name	DR PREETI CHAUHAN
Designation	MD SCHOLAR
Affiliation	POST GRADUATE INSTITUTE OF AYURVEDA JODHPUR JODHPUR
Address	M. NO. 116 SAJJAN LEELA VIHAR NANDARI JODHPUR M. NO. 116 SAJJAN LEELA VIHAR NANDARI JODHPUR Jodhpur RAJASTHAN 342015 India
Phone	7976770885
Fax
Email	guddichauhan66666@gmai.com

Details of Contact Person
Public Query

Name	DR PREETI CHAUHAN
Designation	MD SCHOLAR
Affiliation	PGIA JODHPUR
Address	M. NO. 116 SAJJAN LEELA VIHAR NANDARI JODHPUR M. NO. 116 SAJJAN LEELA VIHAR NANDARI JODHPUR Jodhpur RAJASTHAN 342015 India
Phone	7976770885
Fax
Email	guddichauhan66666@gmai.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	PREETI CHAUHAN
Address	ROOM NO. 104 P.G. DEPARTMENT OF SWASTHAVRITTA AND YOGA, POST GRADUATE INSTITUTE OF AYURVEDA RESEARCH AND STUDIES IN DR SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR RAJASTHAN
Type of Sponsor	Research institution and hospital

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 SAURABH AGARWAL	SANJIVANI HOSPITAL	ROOM NO 8 DEPARTMENT OF SWASTHVRITTA AND YOG SANJIVANI HOSPITAL DSRRAU JODHPUR RAJ Jodhpur RAJASTHAN	09972143436 Drsaurabh101@gmai.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IEC	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E660\|\|Obesity due to excess calories. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), (2) ICD-10 Condition:E669\|\|Obesity, unspecified. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: madhudaka, Reference: sharangdhar madhyam khanda 2/116-117, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 96(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: triushnadi mantha, Reference: charak sutrasthan 23/18, Route: Oral, Dosage Form: Mantha, Dose: 96(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	16.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	The Patient Age Between 16-65 Years Irrespective Of Their Caste, Race And Sex Etc. BMI Greater Than 25 And Above. The Patient Having Clinical Signs & Symptoms Of Obesity. The Patient Should Not Be On Any Other Medicine For Atisthoulya.

ExclusionCriteria

Details

Patient With Endocrinal Disorder (D.M.) And Other Systemic Disease.
Patient With Long Term Steroid Treatment.
The Patient Having Obesity With Secondary In Origin.
Pregnant Women
Drug Induced Obesity.
Patient Who Has BMI Less Then 25

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
REDUCTION IN SIGN AND SYMPTOMS OF ATISTHOULYA BY DECREASING BMI BREATHLESSNESS SNORING	SIX WEEKS

Secondary Outcome

Outcome	TimePoints
IMPROVEMENT IN SUBJECTIVE AND OBJECTIVE ASSESSMENT CRITERIA OF ATISTHOULYA SUCH AS LESSER BMI	45 DAYS
NIL	NIL

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)

18/12/2025

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="0"
Months="1"
Days="15"

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

AN EXPLORATRY STUDY WILL BE DONE ON TWO GROUPS EACH CONSISTING 30 PATIENTS. ONE GROUP WILL BE ADMINISTERED MADHUDAKA IN QUANTITY OF 2 PAL OR 96GMS O.D. AND OTHER GROUP WILL BE ADMINISTERED TRIYUSHNADI MANTHA IN QUANTITY OF 2 PAL OR 96GMS O.D. FOR 45 DAYS. THEN PATIENTS WILL BE ASSESS BEFORE AND AFTER THE TRIAL ON THE BASIS OF SUBJECTIVE AND OBJECTIVE CRITERIA OF ATISTHOULYA AND FOLLOW UP WILL BE DONE EVERY 15TH DAY. THE DATA WILL BE COLLECTED AND ANALYZED STATISTICALLY USING APPROPRIATE TESTS.