| CTRI Number |
CTRI/2026/01/102346 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and usefulness of the Ayurvedic Formulation Vasaguduchyadi Ghanavati in Fatty Liver Disease (not Alcoholic) |
|
Scientific Title of Study
|
Pharmacognostic and Phytochemical Standardization of Vasaguduchyadi Ghanavati and its Preclinical Safety and Clinical Efficacy in 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 |
Dr Amit Kumar Taraphdar |
| Designation |
Professor of Dravyaguna Vigyana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna , Room no- T-7, Institute of Post
Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gnail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Taraphdar |
| Designation |
Professor of Dravyaguna Vigyana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna , Room no- T-7, Institute of Post
Graduate Ayurvedic Education and Research at SVSP Hospital.
294/3/1 A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gnail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jishma Saha |
| Designation |
PG Scholar |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
Dept. of Dravyaguna, Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital, 294/3/1 A.P.C Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
7005808537 |
| Fax |
|
| Email |
sahajishma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of post graduate ayurvedic education and research at SVSP Hospital, Govt.
of West Bengal. 294/3/1, A.P.C. Road, Kolkata- 700009 |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
| Address |
294/3/1, A.P.C. Road, Kolkata- 700009 |
| 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 Amit Kumar Taraphdar |
Institute of post graduate ayurvedic education and research at SVSP Hospital |
Dept. of Dravyaguna
Vijnana, Room no- T2,
Institute of Post Graduate
Ayurvedic Education and
Research at SVSP Hospital.
294/3/1 A.P.C Road,
Kolkata, West Bengal
700009
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
09874849650
atipgaer@gnail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IPGAE&R at SVSP Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K739||Chronic hepatitis, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasaguduchyadi Ghanavati, Reference: Astanga Hridaya Chikitsa Sthana (16/13), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasaguduchyadi Kashayam, Reference: Astanga Hriday Chikitsa Sthana 16/13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 60 years
2. Diagnosed with Grade 1 or Grade 2 NAFLD, confirmed by ultrasonography.
3. Presenting with clinical symptoms such as fatigue, indigestion or anorexia
4. Willingness to participate in the trial and provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. History of Alcohol intake more than 20gm per day.
2. Presence of viral hepatitis (HBV, HCV),autoimmune hepatitis, or decompensated cirrhosis.
3. Ongoing use of hepatotoxic medications or participation in another clinical trial.
4.Pregnancy or lactation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in hepatic steatosis (graded by abdominal ultrasonography)
Reduction in serum ALT and AST levels (markers of liver inflammation) |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in ALP, serum bilirubin, fasting glucose, and lipid profile
Hematological parameters (Hb, TLC, platelet count, ESR)
Subjective symptoms (e.g., appetite, fatigue, digestion) using a validated
symptom severity scoring system
Adverse events and safety profile as per WHO causality assessment criteria |
90 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
06/05/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [atipgaer@gnail.com].
- For how long will this data be available start date provided 02-11-2027 and end date provided 25-12-2099?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A single-blind, randomized, interventional clinical trial will be conducted at the OPD and IPD units of IPGAE&R, Kolkata, to evaluate the efficacy of Vasaguluchyadi Ghanavati in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) up to Grade II. The study will enroll a minimum of 84 participants (42 per group).Group A (Test Group) Will receive Vasaguluchyadi Ghanavati for 90 days.Group B (Control Group): Will receive Vasaguluchyadi Kashayam for 90 days.Primary Objective to evaluate the preclinical safety and clinical efficacy including patient-compliance of Vasaguluchyadi Ghanavati in the management of Non-Alcoholic Fatty Liver Disease (NAFLD) up to Grade II, after its pharmacognostic and phytochemical standardization.Secondary Objectives 1. To carry out pharmacognostic identification and standardization of raw herbal ingredients used in Vasaguluchyadi Ghanavati as per classical and modern parameters. 2. To conduct physicochemical and phytochemical profiling of the prepared formulation using standard methods (e.g., HPTLC, TLC, UV-Vis). 3. To perform acute toxicity studies of the formulation in animal models, adhering to OECD guidelines for safety evaluation. 4. To assess the clinical outcomes of Vasaguluchyadi Ghanavati in NAFLD patients (Grade I–II), based on liver function tests, imaging findings (e.g., USG), and validated symptom scoring. 5. To evaluate the organoleptic and patient compliance profile of the Ghanavati form in comparison to the traditional Kashayam. |