CTRI

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CTRI Number

CTRI/2025/02/080413 [Registered on: 12/02/2025] Trial Registered Prospectively

Last Modified On:

24/07/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A Clinical Study on Madhudak and Chavyadi Saktu for Obesity treatment

Scientific Title of Study

A RANDOMISED OPEN LABELED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MADHUDAK AND CHAVYADI SAKTU IN THE MANAGEMENT OF STHAULYA W.S.R TO 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 SWAMI MANMATH SAMBHAPPA
Designation	MD SCHOLAR
Affiliation	INSTITUTE FOR AYURVED STUDIES AND RESEARCH, FACULTY OF AYURVED, KURUKSHETRA
Address	OPD NO 2, PG DEPARTMENT OF SWASTHAVRITTA AND YOGA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD Kurukshetra HARYANA 136118 India
Phone	9284455472
Fax
Email	manmathswami1019@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Swami Manmath Sambhappa
Designation	MD Scholar
Affiliation	Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra
Address	PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Kurukshetra Kurukshetra HARYANA 136118 India
Phone	9284455472
Fax
Email	manmathswami1019@gmail.com

Details of Contact Person
Public Query

Name	DR SWAMI MANMATH SAMBHAPPA
Designation	MD SCHOLAR
Affiliation	INSTITUTE FOR AYURVED STUDIES AND RESEARCH, FACULTY OF AYURVED, KURUKSHETRA
Address	OPD NO 2, PG DEPARTMENT OF SWASTHAVRITTA AND YOGA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD HARYANA 136118 India
Phone	9284455472
Fax
Email	manmathswami1019@gmail.com

Source of Monetary or Material Support

Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra 136118 kurukshetra

Primary Sponsor

Name	Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra
Address	Institute For Ayurved Studies and Research, Faculty of Ayurved, shri krishna ayush university sector 8 umri road kurukshetra
Type of Sponsor	Other [GOVERNMENT AYURVEDIC COLLEGE]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Seema Rani	Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana	OPD No. 2, PG Department of Swasthavritta and Yoga, Institute For Ayurved Studies and Research, Shri Krishna AYUSH University,sector 8 umri road Kurukshetra 136118 Kurukshetra HARYANA	9466786108 seemaranimd@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE	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: MEDOR,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: chavyadi saktu, Reference: chakradatta 36, Route: Oral, Dosage Form: Sattu, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Madhudak, Reference: chakradatta 36, Route: Oral, Dosage Form: Dravaka, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Patient willing to sign the consent form. 2. The patients between the age group of 20 to 60 years of either sexpresenting with clinical features of Sthaulya (obesity). 3. Patients having BMI above 30kg/m2 To 35kg/m2

ExclusionCriteria

Details

1.Age below 20 and above 60 years.
2.Patients with complicated and history of chronic disorder or any health challenging diseases.
3.Patient having BMI below 29.9 kg/m2.
4.Patients having obesity due to secondary causes (DM, Hypertension) Systemic illness like history of any life threatening disease.
5.Hypothyrodism
6.Steroids induced Obesity

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1)To study the etiopathogenesis of Sthaulya(Obesity) as per Ayurveda and modern point of view. 2)A Comparative Study To Evaluate The Efficacy of Chavyadisaktu and Madhudak and In The Management of Sthaulya W.S.R To Obesity	Follow up of all groups will be done at an interval of 0days,15days, 30days, 45days, 60days.

Secondary Outcome

Outcome	TimePoints
Madhudak is better than chavyadisaktu in sthualya .	Follow up of all groups will be done at an interval of 0days,15days, 30days, 45days, 60days.

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

Phase 2

Date of First Enrollment (India)

01/03/2025

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

Sthaulya has been mentioned in Ayurvedic texts from ancient times, including the Samhitas, Sangraha, Grantham, Nighantu, and others. The illness known as Sthaulya is brought on by an Excessive buildup of fat, or Meda Dhatu, in the body. Acharya Charaka Sthaulya is explained in Asthaninditiyo Adhyaya1. It says that in Astauninditiya Adhyaya, Sthaulya is most difficult to treat, It comes under Santarpniya vyadhi2. According to WHO Obesity come under top 10 selected risk disease.BMI >.24.9 consider overweight, BMI > 30 obese. In 2022, 1 in 8 people in the world were living with obesity3. Worldwide adult obesity has more than doubled since 1990, and adolescent obesity has quadrupled.In 2022, 2.5 billion adults (18 years and older) were overweight. Of these, 890 million were living with obesity.In 2022, 43% of adults aged 18 years and over were overweight and 16% were living with obesity.In 2022, 37 million children under the age of 5 were overweight..Over 390 million children and adolescents aged 5–19 years were overweight in 2022, including 160 million who were living with obesity.14 Madhudak explained by Acharya chakradatta in which take madhu with water at early morning with empty stomach.8 Chakradatta has mentioned Chavyadi Saktu in sthaulya chikitsa adhikar for the management of Sthaulya 8 Obesity and its attendant conditions have become major health problems worldwide and obesity is currently ranked as the fifth most common leading cause of death globally. The WHO defines obesity as an Abnormal or Excessive fat accumulation that may impair health “further clarifying that the fundamental cause of obesity and overweight is an energy imbalance between calories consumed and calories expended.” As body fat itself is not a disease, of course. But when your body has too much extra fat accumulation, it can change the way it functions. These changes are progressive, can worsen over time, and they can lead to adverse health effects.