| CTRI Number |
CTRI/2025/09/094779 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Virechana Karma in Non-Alcoholic Fatty Liver Disease(NAFLD) |
|
Scientific Title of Study
|
Clinical evaluation of Virechana Karma in Non-Alcoholic Fatty Liver Disease(NAFLD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anchal Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD NO. 24 Department of Panchkarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
6395530356 |
| Fax |
|
| Email |
choudharyanchal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD NO. 24 Department of Panchkarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar |
| Address |
OPD NO. 24 Department of Panchkarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul Campus, Uttarakhand Ayurved University, Haridwar 249404 |
|
|
Primary Sponsor
|
| Name |
Gurukul Campus, Uttrakhand Ayurved University, Haridwar |
| Address |
OPD No. 24, Department of Panchkarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar |
| 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 Anchal Choudhary |
Gurukul Campus, Uttarakhand Ayurved University, Haridwar |
OPD No.24,Department of Panchkarma, Gurukul Campus, Uttarakhand Ayurved University, Haridwar, 249404
Hardwar
UTTARANCHAL |
6395530356
choudharyanchal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UTTARAKHAND AYURVED UNIVERSITY, DEHRADUN office of Campus Director/Principal Gurukul Campus, Haridwar-249404 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak Chikitsa 13/61, Procedure details: Deepana-Pachana, Snehana & Swedana will not be done before Virechana. Sadaya Virechana will be given after that Laghu Ahara will be advised.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 16 to 60 years.
2.Fatty liver grade1-2.
3.An individual fit for Virechana Karma. |
|
| ExclusionCriteria |
| Details |
1.History of Liver transplantation.
2.Pregnant and breastfeeding women.
3.Patients who consume alcohol.
4.Patients having uncontrolled diabetes, Hypothyroidism, Hypertension and other life-threatening diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement will be assessed on the basis of Subjective parameters-
1.Fatigue
2.Abdominal pain
3.Nausea and Vomiting
4.Abdominal distension
5.Loss of appetite |
Outcome will be assessed at baseline,30th and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
LFTs
Lipid Profile
USG
BMI |
At baseline and 60th 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/09/2025 |
| 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="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 study is Single arm clinical study to evaluate the efficacy of Virechana Karma in Non-Alcoholic Fatty liver disease(NAFLD). The study will be conducted at Gurukul Campus, Uttarakhand Ayurved University, Haridwar in 30 patients. The assessment will be done on the basis of Subjective and Objective parameters. The study will be conducted at OPD/IPD level of PG Department of Panchkarma. The result will be tabulated and statistically analyzed using appropriate tests. |