| CTRI Number |
CTRI/2026/02/104663 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate an Investigational Product for Improving Liver Health, Including Non-Alcoholic Fatty Liver Disease (NAFLD) |
|
Scientific Title of Study
|
Clinical study to assess the effectiveness of an investigational product in improving the health status of subjects in Improving the Liver Function including 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 SIMADRI BHUSAN NAYAK |
| Designation |
Professor & Head Kayachikitsa |
| Affiliation |
Government Ayurvedic College Balangir |
| Address |
Department of Kayachikitsa
Tulsi Nagar Balangir Odisha
Balangir
ORISSA
767001
India |
| Phone |
9437188796 |
| Fax |
|
| Email |
drsimadri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur Research and Development Centre Dabur India limited |
| Address |
HOD Room - Healthcare
22 Site IV Sahibabad Industrial Area Sahibabad Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
07975843079 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur Research and Development Centre Dabur India limited |
| Address |
HOD room - Healthcare
22 Site IV Sahibabad Industrial Area Sahibabad Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
07975843079 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited
Represented by Dabur Research and Development Centre
22 Site IV Sahibabad Industrial Area Sahibabad Ghaziabad 201010
uttarpradesh |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research and Development Centre 22 Site IV Sahibabad Industrial Area Site 4 Sahibabad Ghaziabad Uttar Pradesh 201010 |
| Type of Sponsor |
Other [Ayurveda] |
|
|
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 SIMADRI BHUSAN NAYAK |
Government Ayurvedic College |
Department of Kayachikitsa
Tulsi Nagar Balangir Odisha
Balangir
ORISSA |
9437188796
drsimadri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
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 | Drug | Other than Classical | | (1) Medicine Name: DRDC/2025/006, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: with water), Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults (age 18 to 60) of either sex with BMI greater than 25.00 and less than, equal to 32.00 kgerm2. 2) Confirmed Diagnosis of NAFLD established by imaging (ultrasound/Fibroscan, CT scan or MRI), within 3 months of the screening phase. The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria defined as complying following- a) There is hepatic steatosis by imaging or histology, b) There is no significant alcohol consumption, c) There are no competing aetiologies for hepatic steatosis, d) There are no co-existing causes for chronic liver disease. 3) Liver Steatosis Grade I, II, and III along with hepatomegaly by USG abdomen pelvis/Fibroscan at screening, |
|
| ExclusionCriteria |
| Details |
1) Regular or excessive use of alcohol within 2 years prior to initial screening. 2) Subjects with uncontrolled diabetes and changed medication in the past 3 months. 3. Presence of alternative causes of fatty liver 4) Weight loss morethan10% in the 6 months before the Screening Visit. 5) History of myopathies or evidence of active muscle disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in:1) NAFLD fibrosis score (NFS) 2) Liver Steatosis Grade I, II, and III along with hepatomegaly 3) Parameters of liver function test (LFT) 4) Severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea, loss of appetite, fatigue, itchy skin, and jaundice on 4 points Linkert scale (None, mild, moderate and severe) |
visit 1, 2, 3 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in:
1. Size of spleen and gallbladder by USG.
2. AST to Platelet Ratio Index (APRI)
3. Glycaemic profile assessed by serum levels of insulin, fasting plasma blood sugar and HbA1c
4. Insulin Resistance assessed by HOMA-IR score
5. Anthropometric parameters like body weight, BMI, waist circumference at screening and end of the study.
6. Parameters in lipid profile like total cholesterol, HDL, LDL, triglyceride etc. at screening and end of the study.
|
visit 1, 2, 3 and 4 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="0"
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 present
clinical study is designed to evaluate the effectiveness, safety, and
tolerability of a hepatoprotective investigational product containing a
patented herbal complex in subjects with NAFLD. The study aims to
comprehensively assess improvements in liver health through radiological,
biochemical, metabolic, and symptomatic parameters. Key evaluations include
changes in NAFLD fibrosis score, liver steatosis grading on ultrasound, and
liver function markers such as AST, ALT, ALP, GGT, and bilirubin. Secondary
assessments will include changes in metabolic indicators (insulin, fasting
glucose, HbA1c, HOMA-IR), lipid profile, body weight, BMI, waist circumference,
and relief from NAFLD-associated symptoms such as abdominal pain, nausea, loss
of appetite, fatigue, itchy skin, and jaundice. |