| CTRI Number |
CTRI/2025/11/097047 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Yakritshul Vinasini Vatika and Arogyavardhini Vati in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) |
|
Scientific Title of Study
|
An Open Label Comparative Clinical Trial to evaluate the efficacy of Yakritshul Vinasini Vatika and Arogyavardhini Vati in the management of 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 |
Dr Shubhi Mishra |
| Designation |
P.G. Scholar |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 79 PG Department of Kayachikitsa
Institute for Ayurved Studies and Research, Umri Road, Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9752781669 |
| Fax |
|
| Email |
shubhimishra861@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Lamba |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 79 PG Department of Kayachikitsa
Institute for Ayurved Studies and Research, Umri Road, Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9736333868 |
| Fax |
|
| Email |
drlamba.neha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Lamba |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 79 PG Department of Kayachikitsa
Institute for Ayurved Studies and Research, Umri Road, Sector 8
Kurukshetra
HARYANA
136118
India |
| Phone |
9736333868 |
| Fax |
|
| Email |
drlamba.neha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra pin
136118, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra |
| Address |
Institute For Ayurved Studies And Research, Umri road, sector 8,
Kurukshetra pin 136118 |
| 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 Shubhi Mishra |
Institute for Ayurved Studies and Research |
Room no 56, PG
Department of
Kayachikitsa, Umri
road sector 8
Kurukshetra, pin
136118
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
9752781669
shubhimishra861@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University |
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: YAKRUJJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arogyavardhini Vati, Reference: Rasratan samuccaya, Visharpadichikitsa Chapter 20, Verse 106 to 112, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yakritshul Vinasini Vatika, Reference: Bhaishajya Ratnavali, Chikitsa Sthana Chapter 41 verse 57 to 59, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -karvellka swarasa ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Randomly selected irrespective of their caste, religion and sex.
Non-Alcoholic i.e.Total abstainer of alcoholic intake.
USG confirmed Grade I or Grade II fatty liver.
The patients with signs and symptoms of NAFLD, Yakritroga are mentioned in the text.
The ratio of AST and ALT less than 2
NAFLD diagnosed patients confirmed by USG with or without symptoms like anorexia,
fatigue, and abdominal discomfort.
Both freshly diagnosed and previously diagnosed cases of NAFLD.
Voluntary assigned and enrolment of participants in the study. |
|
| ExclusionCriteria |
| Details |
USG showing grade III fatty liver.
AST and ALT ratio greater than 2
Presence of any other identified cause of liver disease Portal hypertension, Ascites, viral
hepatitis, Liver parenchymal disease, HCC, Wilson disease, Cirrhosis or any other
conditions interfering with the result of the treatment of NAFLD.
Individuals on any anticoagulants.
history of Cardiac Arrhythmia, MI, Acute coronary syndrome, Stroke Syndrome, and other
cardiac symptoms, Severe within the last 6 months, and comorbidities.
Patient with Symptomatic congestive cardiac failure.
Uncontrolled pulmonary function, Diabetes Mellitus, chronic kidney disease other severe
and chronic diseases.
Serum creatinine greater than 1.2mg per dl.
Malignancies, HIV, TB, other infectious diseases
pregnancy and lactating women
Taking Corticosteroids and antidepressants, anti cholinergic, hepatotoxic medications or
any other drugs for more than 6 weeks that influences the outcome of the study.
Alcoholics and any other drug abusers.
Patient has a history of hypersensitivity to the trial drug or any of its ingredients. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This will be assessed based on the improvement in ALT level in the patients of NAFLD |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This will be assessed based on improvement in subjective
parameters and other test parameters i.e. AST level, Alkaline Phosphate, serum cholesterol and
serum triglyceride in the patients of NAFLD. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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 Yet Recruiting |
| 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
|
Over the past few decades, Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) have become leading causes of chronic liver disease worldwide in individuals without significant alcohol intake. Closely linked with obesity, metabolic syndrome, type 2 diabetes, and dyslipidemia, NAFLD develops when liver fat exceeds 5–10% of its weight. In Ayurveda, it is considered a lifestyle-related Yakrit Roga, categorized as Santarpanjanya Vyadhi, caused by overnutrition, oily and spicy foods, and sedentary habits, leading to Kapha dosha prakopa, Agnimandya, and Dooshit Rasa, which impair liver function. Vitiated Kapha and Meda Dhatu accumulate in the liver, obstructing channels and causing hepatomegaly. Most patients are asymptomatic and diagnosed incidentally through LFTs or imaging. Common symptoms include loss of appetite, constipation, flatulence, abdominal discomfort, and nausea. Globally, NAFLD affects about 24% of people; its prevalence is 94% in obese, 67% in overweight, and 25% in normal-weight individuals. In type 2 diabetes, prevalence ranges from 40–70%, with variation by ethnicity and gender. In India, about one-third of adults have NAFLD, with rural Haryana showing a 30.7% prevalence |