| CTRI Number |
CTRI/2025/09/094793 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Two Ayurveda medicines Arogyavardhini Vati and Kumaryasava in non-alcoholic fatty liver disease (Yakrit Vikar) |
|
Scientific Title of Study
|
An open label single arm clinical evaluation of Arogyavardhini Vati with Kumaryasava in the management of Yakriddalyudara (non alcoholic fatty liver disease) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MONIKA GIRI |
| Designation |
PG SCHOLAR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897266496 |
| Fax |
|
| Email |
monikagiri59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish KJ |
| Designation |
PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish KJ |
| Designation |
PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY |
|
|
Primary Sponsor
|
| Name |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY |
| 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 |
| MONIKA GIRI |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
DEPARTMENT OF KAYACHIKITSA OPD NO 13/14, PATANJALI AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR HIGHWAY, 249405, UTTARAKHAND
Hardwar
UTTARANCHAL |
9897266496
monikagiri59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND |
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, (2) ICD-10 Condition:K759||Inflammatory liver disease, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arogyavardhini vati, Reference: Ras Ratna Samucchya 20/87-93, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Kumaryasava), Additional Information: -(2) Medicine Name: Kumaryasava, Reference: Yog Ratnakar 33/156-157, Route: Oral, Dosage Form: Asava, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Grade I and II fatty liver
Elevated SGOT, SGPT, ALP
Newly diagnosed or treated NAFLD cases
Controlled diabetes with fatty liver
Willingness to participate and consent
|
|
| ExclusionCriteria |
| Details |
Hepatitis B,C, autoimmune, drug-induced hepatitis, alcoholic liver disease
Serious systemic illnesses
Grade III fatty liver
Pregnancy/lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in USG grading of fatty liver after 60 days Changes in LFT parameters (SGOT, SGPT, ALP, GGT etc.)
|
First follow-up 4 weeks
Second follow-up 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms such as weakness, anorexia, indigestion, abdominal pain,constipation, vomiting, mild fever, fatigue, excessive thirst |
Baseline, 30thday, 60th day
|
|
|
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 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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) |
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 study is a single arm clinical evaluation of Arogyavardhini vati and Kumaryasava in Yakriddalyudara ( non alcoholic-fatty liver disease). This will be conducted on 60 random selected patients from OPD13,14 of Kayachikitsa department of Patanjali Ayurveda Hospital, Haridwar. First follow-up during treatment - 30th day and second follow-up at the end of treatment i.e. 60th day. Assessment will be done on the basis of subjective and objective parameters as discussed earlier. |