| CTRI Number |
CTRI/2025/01/079324 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Hepatoprotective Activity of Ayurvedic drug formulations |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of liver support formula in patients with nonalcoholic fatty liver disease: A randomized, double blind, interventional, prospective clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no 116 Department of Panchakarma, National Institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no 116 Department of Panchakarma, National Institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assisstant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.113 A, Department of Panchakarma, National institute of Ayurveda, Jorawar Singh Gate, Jaipur, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be University,Jorawar Singh Gate,Jaipur, Rajasthan,India,Pin-302002 |
|
|
Primary Sponsor
|
| Name |
BVG life Sciences Limited |
| Address |
Sagar Complex, Nashik Phata, Opposite Kasarwadi Railway Station, Pune-411 034 |
| 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 |
| Dr Sarvesh Kumar Singh |
National Institute of Ayurveda |
Room no.116,Department of Panchakarma, National Institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN |
08739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National Institute of Ayurveda |
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: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Phalatrikadi Kashaya, Reference: Bhaisajya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Kashaya will be provided in syrup form | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: BVGL21/8, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Kashaya will be provided in syrup form-10 ml(910 mg) twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of hepatic disorder with abnormal LFT with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure
2.Definitive diagnosis of NAFLD (by USG) or NASH by imaging evidence (USG or liver elastography, Metavir scoring F2 and F3 and liver stiffness more than 8kPa)
3.Subjects willing to sign inform consent form |
|
| ExclusionCriteria |
| Details |
1.Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis B or C) and Biliary obstruction
2.AST more than 500 U/L or ALT more than 300 U/L
3. ( Metavir scoring F4 or liver stiffeness more than 17kPa )
4.Suspected hypersensitivity to contents of study drug
5.Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer)
6.Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer
7.Patients with a renal failure
8.Pregnant or lactating women
9.Subjects with Moderate to high Physical activity having energy expenditure of 3.5 to 7 kcal/min
10.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to evaluate the changes in Ultrasound guided Liver elastography at screening and end of the treatment (Metavir scoring F3 to lower and changes in liver stiffeness in pascal) at 12 week from baseline. |
baseline to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluate the changes in serum total bilirubin, AST, ALT, serum Bilirubin |
baseline to 12 weeks |
| Assessment of change in symptoms of liver disease like anorexia, fatigue, abdominal pain, nausea |
baseline to 12 weeks |
| Adverse events profile |
baseline to 12 weeks |
| Compliance and tolerability of the investigational product throughout the study |
baseline to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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
|
In the present clinical study, 90 participants with Non-Alcoholic Fatty Liver Disease ( NAFLD) will be subjected to two ayurvedic formulations in two equally divided arms for 12 weeks. The efficacy and safety of these treatments will be assessed through ultrasound-guided liver elastography, liver function tests (LFT), clinical signs and symptoms, as well as reported adverse events, both observed and self-reported. |