| CTRI Number |
CTRI/2025/04/084477 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Sweating process (swedan) is the treatment of obesity (medovriddhi) |
|
Scientific Title of Study
|
A comparative evaluation of Sagni Sweda and Niragni Sweda on Medovriddhi by biochemical and biophysicals parameter |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmita Yadav |
| Designation |
Pg scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kriya Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7307975326 |
| Fax |
|
| Email |
sushmita97bhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaidya Sushil Dubey |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kriya Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415540732 |
| Fax |
|
| Email |
vaidyaskd@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaidya Sushil Dubey |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kriya Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415540732 |
| Fax |
|
| Email |
vaidyaskd@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University Varanasi Uttar Pradesh 221005 India |
|
|
Primary Sponsor
|
| Name |
Department of Kriya Sharir Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India |
| Type of Sponsor |
Government medical college |
|
|
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 Sushmita Yadav |
Sir Sundarlal Hospital IMS BHU Varanasi Uttar Pradesh 221005 |
Panchkarma department OPD room number 16 C and Kriya Sharir department OPD number 20 .
Varanasi
UTTAR PRADESH |
07307975326
sushmita97bhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Banaras Hindu University Institute of Medical Sciences Varanasi Uttar Pradesh 221005 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOJA-VRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Charak sutra sthan 14 shlok 13, Procedure details: Swedan karma procedure All registered cases referred by a Panchakarma consultant to Sarvang Vashpa Swedan will be explained the Swedan Karma procedure, its benefits, & hemodynamic observation procedure & consent will be obtained.
Purva karma All subjects initially will be given external Snehana by abhyanga to tiltail, 10-15 min. by panchakarma technicians before Swedan karma.Pradhan karma
After Abhyang, the subject will be asked to sit in the Sarvang Swedan chamber, the head is kept outside the box & the body is covered with a thin cloth. Whole-body sudation will allow until signs & symptoms of Samyak Swedan appeared i.e. Sweda pradurbhaw, Gaurav Nigrah, & Mardava. adequate sudation, such as perspiration & an increase in body temperature will be produced.
Following the appropriate sudation, the patient will be wrapped in a blanket & given a 15-minute rest in a closed room. Subsequently, the patient will be permission to remove the blanket & go outside.
)
| | 2 | Comparator Arm | Procedure | - | vyAyAmaH, व्यायामः | (Procedure Reference: Sushrut chikitsa sthan 24 shlok 48, Procedure details: Exercise procedure all the registered cases referred by the consultant to exercise will be explained the exercise
Method of warm-up a warm-up generally consists of a gradual increase in intensity in physical activity joint mobility exercise stretching & slow walking.the total duration of the warm-up exercise will be 5min.
Exercise period Running in place Jumping jack Knee raises Lunge Crunches Squat jump Side bend
Time duration exercise period 20min
Cool down period Biceps stretch Triceps stretch
Shoulder stretch Calf stretch Standing forward bend Supine Time duration of the cool-down period will be 5min 5 days exercise & 2 days rest & then repeats Total duration of exercise period 28 days
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group from 20 to 50 yrs irrespective of sex religion economic status and race
Patients having signs and symptoms of Medovriddhi as per classical text
Diagnosed and confirmed cases of Medo-vriddhi based on subjective and objective criteria
patients willing to enroll in the study
Diagnosed based inclusion criteria
Classical signs and symptoms of Medovriddhi
BMI 25 to 34.9 kg per m2
Waist circumference more than 94 cm in men and more than 80cm in women
WHR more than 0.9 in men more than 0.8(women)
ATP III classification as per National Cholesterol Education Program (NCEP) guidelines
a Serum cholesterol more than 200mg per dl
b Serum triglyceride more than 150mg per dl
c Serum LDL more than 130mg per dl
d Serum VLDL more than 40mg per dl
e Serum HDL less than 40mg per dl
Either cholesterol or triglyceride or both will be increased than the normal value will be included because all the parameters increase may not be present in every patient. |
|
| ExclusionCriteria |
| Details |
patients not fulfilling signs and symptoms of Medovriddhi as per classical text
subjective and objective criteria not fulfilling
age group less than 20 and more than 50 yrs.
BMI more than 35kg per m2
Pregnant and lactating women
Serum cholesterol more than 240mg per dl
LDL more than 190mg per dl
Triglyceride more than 500mg per dl
Patients suffering from any severe systemic disease
patients suffering from hypothyroidism cardiovascular disease chronic diabetes endocrinal and metabolic disorder COPD inflammatory and infectious disease
genetic conditions like Down syndrome
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Impact of Swedan Karma and exercise on bmi waist and hip circumference and waist and hip ratio and lipid profile
|
Baseline assessment and every seventh days till one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare impact of swedan karma and exercise on bmi waist hip circumference waist hip ratio and lipid profile |
Baseline assessment and after one month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
14/04/2025 |
| 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 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
|
Patients will be randomly divided into two groups GROUP A will be done the sarwang swedan procedure for 7 days then 7 days rest again repeat the procedure and GROUP B will be done exercise for 5 days and 2 days rest then again repeat the procedure. Treatment Period 28 days. Follow up period every 7 days . |