| CTRI Number |
CTRI/2025/02/080633 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate the Efficacy and Safety of Dipya Liver Care Tablet in the Management
of NAFLD.
|
|
Scientific Title of Study
|
Open-Label, Prospective, Randomized, Single-Arm Clinical Trial to Evaluate
the Efficacy and Safety of Dipya Liver Care Tablet 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 V R Borakhade |
| Designation |
Director Post graduate and Research Centre |
| Affiliation |
Yashwant Ayurvedic College PGTand RC Kodoli |
| Address |
Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur 416114 affiliated Yashwant Charitable Hospital Kodoli Kolhapur Maharashtra State India Department Kayachikitsa Ground Floor Room No 15
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
023282220088 |
| Fax |
|
| Email |
yamkodoli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V R Borakhade |
| Designation |
Director Post graduate and Research Centre |
| Affiliation |
Yashwant Ayurvedic College PGTand RC Kodoli |
| Address |
Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur 416114 affiliated Yashwant Charitable Hospital Kodoli Kolhapur Maharashtra State India Department Kayachikitsa Ground Floor Room No 15
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
023282220088 |
| Fax |
|
| Email |
yamkodoli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V R Borakhade |
| Designation |
Director Post graduate and Research Centre |
| Affiliation |
Yashwant Ayurvedic College PGTand RC Kodoli |
| Address |
Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur 416114 affiliated Yashwant Charitable Hospital Kodoli Kolhapur Maharashtra State India Department Kayachikitsa Ground Floor Room No 15
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
023282220088 |
| Fax |
|
| Email |
yamkodoli@gmail.com |
|
|
Source of Monetary or Material Support
|
| vedistry Pvt.Ltd
21 Evergreen Industrial Estate
Off E Moses Road Mahalaxmi
Mumbai 400011 |
|
|
Primary Sponsor
|
| Name |
Dr Madhura Dhatrak |
| Address |
21 Evergreen Industrial Estate
Off E Moses Road Mahalaxmi
Mumbai 400011
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSandip Mali |
21 Evergreen Industrial Estate
Off E Moses Road Mahalaxmi
Mumbai 400011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vasudha Borakhade |
Yashwant Charitable Hospital Kodoli Kolhapur 416114 |
Kodoli Tal Panhala Dist Kolhapur 416114 Maharashtra State India Department Kayachikitsa
Ground Floor Room No 15
Kolhapur
MAHARASHTRA |
09822885710
vasudha.borakhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YASHWANT AYURVEDIC COLLEGE POST GRADUATE TRAINING AND RESEARCH CENTRE |
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: Vedistry Livercare Tablet , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female participants aged 18-45 years diagnosed with NAFLD Grade II
2 Participants with abnormal liver function tests indicative of NAFLD
3 Completed the screening process within 3 days prior to randomization
4 Study participants have understood and signed the informed consent form to participate in the
study
5 Study participants willing to be available for the entire study period and adhere to protocol
requirements as evidenced by signing the informed consent document |
|
| ExclusionCriteria |
| Details |
KEY EXCLUSION CRITERIA -
1. Participants with significant hepatic disease other than NAFLD (e.g., viral hepatitis, alcoholic liver
disease, Liver ci).
2. History of major gastrointestinal surgery or liver transplantation.
3. Pregnant or lactating women.
4. Concurrent use of hepatotoxic drugs or participation in another clinical trial within the past 30
days.
5.Alcohol consumption: Excessive alcohol consumption, defined as more than 20 grams per day for
men and more than 10 grams per day for women, within two years of entry
6.Viral infection: Evidence of hepatitis B or C infection
7.Autoimmune or liver condition: History of autoimmune hepatitis, Wilson's disease, or other
underlying liver conditions
8.Other conditions: Short bowel syndrome, suspected or confirmed hepatocellular carcinoma, HIV
positivity, low alpha-1-antitrypsin level, glycogen storage disease, dysbetalipoproteinemia,
phenotypic hemochromatosis, vascular lesions, iron overload, and more
9.Active drug use: Active drug use or dependence that would interfere with follow-up |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Mean change in liver function as assessed by Liver Function Tests over 90 days
2 Reduction in hepatic stiffness and scarring measured by Fibro scan at baseline and day 90
3 Improved digestive health using the Digestion associated quality of Life and
Gastrointestinal Symptom Rating Scale
4 Changes in Lipid Profile over 90 days |
1 Screening Day Before 2 to 4
2 Visit 1 Day 0
Randomization in study
3. Visit 2 Day 30
4. Visit 3 Day 60
5. Visit 4 Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY ENDPOINT -
1. Safety evaluations based on hematological (ESR, Leukocyte) and renal function tests (RFTs)
2. Understand AEs and SAEs of liver care tablet over 90 days |
1. Screening (Day -2 to -4)
2. Visit 1(Day 0): Randomization in study
3. Visit 2 (Day 30)
4. Visit 3 (Day 60)
5. Visit 4 (Day 90) |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
02/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmadhuradhatrak@charak.com].
- For how long will this data be available start date provided 22-06-2025 and end date provided 22-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Vedistry Liver Care Tablet is an Ayurvedic formulation designed for liver detoxification, managing Non-Alcoholic Fatty Liver Disease (NAFLD), hepatitis, alcoholic liver disease, cirrhosis, and compromised liver function. It claims to enhance liver function, reduce hepatic fat and lipid levels, and improve digestion. A Phase IV Open-Label, Prospective, Randomized, Single-Arm Clinical Trial involving 35 participants over 90 days evaluates its efficacy and safety. Participants visit at baseline (Day 0), Day 30, Day 60, and Day 90, with assessments of liver function, lipid profiles, and digestive health. Primary endpoints include changes in liver function tests (AST, ALT, Bilirubin), hepatic fat reduction via Fibroscan, and improved digestion measured by the Digestion Quality of Life (DQLQ) and Gastrointestinal Symptom Rating Scale (GSRS). Secondary endpoints include lipid profile improvements (cholesterol, triglycerides) and liver stiffness reduction. Safety evaluations encompass hematological, renal, and physical examinations, along with monitoring for adverse events. Participants receive 1 tablet twice daily after meals. Key exclusions include individuals with significant liver diseases beyond NAFLD, viral hepatitis, autoimmune hepatitis, active alcohol or drug use, and specific medical conditions. Ethical guidelines, including informed consent and adherence to Good Clinical Practice (GCP), are strictly followed. The trial aims to validate Vedistry Liver Care Tablet as a safe and effective option for improving liver health and metabolic function, positioning it as a promising Ayurvedic solution for NAFLD and related conditions. |