| CTRI Number |
CTRI/2026/01/101735 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of ayurvedic medicine with and without Panchakarma procedure in the management of Sthaulya w.s.r. to Obesity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Trayushanadi Loha with and without Virechana 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 Kavita Gupta |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7888901900 |
| Fax |
|
| Email |
kavitaguptamlt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parveen Kumar |
| Designation |
Professor and HOD of Panchakarma |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7589303536 |
| Fax |
|
| Email |
drparv1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Gupta |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, India
Jalandhar
PUNJAB
144008
India |
| Phone |
7888901900 |
| Fax |
|
| Email |
kavitaguptamlt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, 144008, India |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College and Hospital Jalandhar |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, opp Burlton Park, Jalandhar, Punjab, 144008, India |
| Type of Sponsor |
Private 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 Kavita Gupta |
Dayanand Ayurvedic Hospital Jalandhar |
OPD NO 2
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg Jalandhar Punjab India
Jalandhar
PUNJAB |
8054004479
kavitaguptamlt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak Sutra 21, Procedure details: DAY 1-5 Deepana & pachana will be performed with trikatu churan 3 gm twice daily before food with lukewarm water till the appropriate symptoms of agni deepana is attained.snehpana increasing dose with Triphala ghrit will be done with proper oleation features will achieved .During the gap of 3 days & day of virechana sarvanga abhyanaga will be done followed by swedana.
Virechana karama will be performed by the administration of trivritta avaleha dose mat vary as per the kostha & agni of patient.
Samsarjana karma will be advised for 3 - 7 days depends upon the shudhi.
Maximum duration for procedure will be 23 days.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayushanadi Loha, Reference: Yog Ratankar Medoroga Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnoised as per mentioned criteria and willing for study
2.Subjects between 16 and 45 years irrespective to gender
3.Subjects having BMI 30-34.4 KG/M2
4.Postpartum more than 1 year
5.Fit for virechana Procedure |
|
| ExclusionCriteria |
| Details |
1.Subjects not willing for study
2.Pregnant and lactating women will be excluded
3.Subjects having any other major complicated diseases like Diabetes Mellitus, Cardiac Diseases, Renal disorders, Thyroid disorders, HTN, Malignancy ,Drugs induced, PCOS AND PCOD |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in the clinical symptoms of obesity
1.Ati Kshudha
2.Ati Pipasa
3.Ati Sweda
4.Alasya
5.Kshudra Shwasa
6.Dourbalaya |
Day 0, 20th, 40th, 60th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Body weight
2.Body mass index
3.Waist -hip ratio
4.Mid arm circumference
5.Chest Circumference
6.Abdominal Girth
7.Thigh Circumference |
Day 0 ,Day 20th ,Day 40th Day 60th |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="6"
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
|
The total of 60 patients will be selected who are between age group of 16 to 45 years of either sex who are diagnosed with Sthaulya on the basis of sign and symptoms. Patients will be divided into two groups (Trial Group A and Trial Group B). Group A will be intervene with Virechana along with Oral Administartion of Trayushanandi Loha and Group B will be intervene with Oral medication Trayushanadi Loha and conduct a clinical study - To evaluate the efficacy of Tryaushanadi Loha in the management of Sthaulya w.s.r to Obesity,To evaluate the efficacy of Virechana along with Oral Administration of Trayushanandi Loha in the management of Sthaulya w.s.r to Obesity, To Compare the difference of efficacy of Oral administration of Trayushanadi Loha with and without Virechana in the management of Sthaulya w.s.r to Obesity. |