| CTRI Number |
CTRI/2025/10/096543 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [TREATMENT ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
THIS IS THE CLINICAL STUDY TO CHECK THE WEIGHT LOSS WITH UDWARTANA AND NITYAVIRECHANA PROCEDURE IN THE PEOPLE WITH OBESITY |
|
Scientific Title of Study
|
AN OPEN LABELLED CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF TWO FORMS OF APATARPANA CHIKITSA IN STHAULYA W.S.R TO OVERWEIGHT AND OBESITY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHREENIDHI |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI |
| Address |
DEPARTMENT OF PANCHAKARMA
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI KARNATAKA INDIA
Udupi
KARNATAKA
574118
India |
| Phone |
9108013923 |
| Fax |
|
| Email |
bhatnidhisvr99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJALAXMI MG |
| Designation |
PROFESSOR |
| Affiliation |
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI |
| Address |
DEPARTMENT OF PANCHAKARMA
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI KARNATAKA INDIA
Udupi
KARNATAKA
574118
India |
| Phone |
9448951673 |
| Fax |
|
| Email |
drrajalaxmisdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJALAXMI MG |
| Designation |
PROFESSOR |
| Affiliation |
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI |
| Address |
DEPARTMENT OF PANCHAKARMA
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI KARNATAKA INDIA
Udupi
KARNATAKA
574118
India |
| Phone |
9448951673 |
| Fax |
|
| Email |
drrajalaxmisdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE UDUPI |
|
|
Primary Sponsor
|
| Name |
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE UDUPI |
| Address |
DEPARTMENT OF PANCHAKARMA
SDM AYURVEDA COLLEGE, HOSPITAL AND RESEARCH CENTRE, LAXMI NAGAR KUTHPADY UDUPI |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHREENIDHI |
SDM AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF PANCHAKARMA SDM AYURVEDA COLLEGE HOSPITAL AND RESEARCH CENTRE
LAXMI NAGAR
KUTHPADY
UDUPI
574118
Udupi
KARNATAKA |
9108013923
bhatnidhisvr99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA UDUPI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: ASHTANGA HRIDAYA SUTRASTANA 2/15, Procedure details: UDWARTANA
Purva Karma:
This includes preparation of the patients and the patients are thoroughly examined. The Prakriti
and saara of patient are assessed and documented. The disease is also examined. It is confirmed if
the patient is fit to undergo Udvartana treatment or not. Then preparation for the treatment like
material needed for the treatment are collected beforehand. Udwartana ideally should be done in
the morning after evacuation of bowel and bladder.
Pradhana Karma:
It is important that udvartana should be done simultaneously and synchronously from both sides
of the body to maintain uniformity. It is done covering all the 7 postures.
• Position 1- patient sitting on the massage table with lower limbs extended.
• Position 2- patients lying on his back. (supine)
• Position 3-patients lying on one side, turning towards left (left lateral)
• Position 4- patients lying on his belly, face downwards (prone)
• Position 5- patients lying on other side, turning towards right (right lateral)
• Position 6- repeat position 2, patients lying on his back, facing upwards (supine)
• Position 7- repeat position 1, patients sitting with legs extended.
Duration: Each part of the body in their respective positions is massaged for 3-5 minutes.
Usually the duration of Udvartana is 30 minutes.
Paschat Karma:
After Udvarthana, the body of the patient will be wiped off with cloth, later the patient is advised to
take rest till the cessation of sweat, then the patient is advised to take hot water bath.
DURATION OF THE STUDY
Duration of treatment- 7 days)
(1) Medicine Name: Musta, Aragwadha, paata, triphala, devadharu, shwadanstra, kadira, nimba, haridra, twak, vatsaka, Reference: CHARAKA SAMHITA SUTRASTANA 23/12, Route: Topical, Dosage Form: Churna/ Powder, Dose: 430(g), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म nitya | (Procedure Reference: CHARAKA SAMHITA SUTRASTANA 16/13, Procedure details: The patients who are fulfilling the above said criteria will be selected for Nitya Virechana for 7
days. The patient will be administered with Triphala bhavitha katuki choorna in empty stomach,
in a dose of 3 g with ushna jala as anupana at 7 am. After the administration, the subject will be
observed for number of vegas, assessment of jeerna and ajeerna lakshanas of virechana dravya,
Once the samyak viriktha lakshana is achieved, then patient is asked to take laghu aahara.)
(1) Medicine Name: TRIPHALABHAVITA KATUKI CHOORNA , Reference: CHARAKA SAMHITA SUTRASTANA 4 /9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria.
Subjects aged between 16-70 years of either gender
Subjects who are fit for nitya virechana and udwartana
Subjects whose BMI is above 25 upto 40kg/m2
|
|
| ExclusionCriteria |
| Details |
Morbid obesity
Obesity due to endocrinal abnormalities
Subjects presented with cardiovascular and cerebrovascular diseases
Subjects with diabetes mellitus and hypertension
Pregnant and lactating women
Subjects who are not fit for nitya virechana and udwartana |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BMI |
0th day and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric features (measuring skin fold thickness using the slide callipers), Triceps, Biceps,
Subscapular, Abdomen and Thigh.
Measurement taken at various levels
Chest
Abdomen
Thigh
Buttock
Waist-hip ratio
Chala-sthana, udara, sphik
Kshudha adhikya
Atipipasa
Nidradhikya
Daurgandya
Shareera Gaurava |
0th day and 7th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2025 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is an open label interventional clinical study to evaluate the combined effect of nitya virechana and udwartana in the management of sthaulya with special reference to overweight and obesity on day 0 and day 7 of intervention based upon subjective and objective parameters. |