| CTRI Number |
CTRI/2026/03/106216 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical trial to study the effects of Ayurvedic medicine in patients with liver problems |
|
Scientific Title of Study
|
An Open-Label Pilot Study of OLILIV Juice to Assess Efficacy and Safety in Mild to Moderate Hepatic Dysfunctions |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OL-Oliliv-0126 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srikanta Pandit |
| Designation |
Professor and Head, Department of Kayachikitsa |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Research Unit
Heritage Building
Room No. 301-302
Department of Kayachikitsa
J. B. Roy State Ayurvedic Medical College and Hospital
Dept. of Health and Family Welfare (AYUSH)
Kolkata
WEST BENGAL
700004
India |
| Phone |
09831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srikanta Pandit |
| Designation |
Professor and Head, Department of Kayachikitsa |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Research Unit
Heritage Building
Room No. 301-302
Department of Kayachikitsa
J. B. Roy State Ayurvedic Medical College and Hospital
Dept. of Health and Family Welfare (AYUSH)
Kolkata
WEST BENGAL
700004
India |
| Phone |
09831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Supriti Choudhury |
| Designation |
Director, Medi Hero Biotech LLP |
| Affiliation |
Medi Hero Biotech LLP |
| Address |
Medi Hero Biotech LLP
Aditya Bhawan
First Floor
148 Jessore Road, Nager Bazar, Satgachi, Kolkata
Kolkata
WEST BENGAL
700074
India |
| Phone |
08240437563 |
| Fax |
|
| Email |
biotechmedihero@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medi Hero Biotech LLP
Aditya Bhyavan
First Floor
148 Jessore Road, Aditya Bhawan
Nagerbazar, Satgachi, Kolkata, West Bengal 700074
|
|
|
Primary Sponsor
|
| Name |
Medi Hero Biotech LLP |
| Address |
Aditya Bhyavan
First Floor
148 Jessore Road, Aditya Bhawan
Nagerbazar, Satgachi, Kolkata, West Bengal 700074
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Srikanta Pandit |
Research Unit J. B. Roy State Ayurvedic Medical College and Hospital |
Research Unit
Heritage Building
Room No. 301-302
Department of Kayachikitsa
J. B. Roy State Ayurvedic Medical College and Hospital
Dept. of Health and Family Welfare (AYUSH)
170-172 Raja Dinendra Street, Kolkata 700004
Kolkata
WEST BENGAL |
09831723650
srikantapandit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, J. B. Roy State Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 | Other than Classical | | (1) Medicine Name: OLILIV Juice, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of liver dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right upper quadrant discomfort).
AST and ALT greater than 40 IU per L.
AST and ALT ratio greater than 0.8.
BARD score equal or greater than 2. |
|
| ExclusionCriteria |
| Details |
Poorly-controlled diabetes, hypertension or CKD.
Radiologic imaging consistent with cirrhosis or portal hypertension.
Participants having hypersensitive predisposition or hypersensitive to test medicine.
Pregnant woman, lactating woman, and woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception during the study.
Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hepatic function, AST and ALT ratio, BARD score, Fibrosis Risk Score and Lipid profile |
Baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Laboratory safety parameters (FBS, CBC, LFT and kidney function tests) |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
01/04/2026 |
| 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="0"
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
|
It’s an open-label,
exploratory retrospective pilot study. The primary goal is to determine whether
OLILIV Juice is effective in reducing liver enzymes (AST, ALT, AKP, GGT) from
baseline to end of the study [Time Frame 8 weeks]. The single arm trial aims to
recruit 24 participants who meet the selection criteria of presence of liver
dysfunction symptoms (e.g., abdominal pain, fatigue, loss of appetite, right
upper quadrant discomfort), AST and ALT greater than 40 IU per L, AST and ALT ratio
greater than 0.8 or BARD score equal or greater than 2. The treatment will
continue for 8 weeks with 30 ml of OLILIV Juice taken twice before meals. Before and after 8
weeks of treatment, the following examinations will be performed: BMI, Efficacy
Blood Test (CRP, Platelet, FBG, HbA1c, Lipid profile, LFT, GGT), and Safety
Assessments (CBC, LFT, BUN, Creatinine). The endpoint variables will be
analyzed using Chi-square, t-test, 95 percent confidence interval, and ANOVA,
as appropriate. P-values less than 0.05 will be considered statistically
significant. |