| CTRI Number |
CTRI/2019/12/022578 [Registered on: 31/12/2019] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation for the efficacy of Muliv strong syrup in the management of Non- Alcoholic Fatty Liver disease (NAFLD). |
|
Scientific Title of Study
|
An open label Clinical trial to evaluate the efficacy of Muliv Strong Syrup in the management of Non- Alcoholic Fatty Liver disease (NAFLD). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Registered elsewere |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Panchakarma, National Institute of Ayurveda, Madhav Vilas palace, Jorawarsingh gate
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Shekhar Tiwari |
| Designation |
Medical Advisor |
| Affiliation |
Multani Pharmaceuticals Ltd. |
| Address |
Medical advisor room, Pharmacy division, Multani Pharmaceuticals Ltd.
New Delhi
New Delhi
DELHI
110020
India |
| Phone |
|
| Fax |
|
| Email |
dr.hstiwari@multani.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Sharma |
| Designation |
Associate Professor (Co investigator) |
| Affiliation |
National Institute of Ayurveda |
| Address |
OPD no 2, PG Dept. of Panchakarma Department, National institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
|
| Fax |
|
| Email |
sumanhp2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multani Pharmaceuticals Ltd., New Delhi |
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Ltd |
| Address |
T 10, Okhla Industrial area, Phase II, Okhla, New Delhi-110020 |
| 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 Gopesh Mangal |
National Institute of Ayurveda |
OPD room no 2 and IPD, PG Department of panchakarma, Madhav vilas palace, Jaipur 302002, Rajasthan.
Jaipur
RAJASTHAN |
8619849011
gmangal108@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: K758||Other specified inflammatory liverdiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muliv Strong Syrup |
Muliv Strong Syrup orally 10 ml TDS before meal for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex not taking any medicine will be included in the study.
2. Individuals suffering from NAFLD with or without elevated liver enzymes or hepatomegaly will be included.
3. Patients willing to give informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with chronic hepatitis (more than 3 months), Patients with malignant jaundice, patient with acute hepatitis (Other than infective).
2. Individuals with known hypersensitivity to ingredients of study products; individuals with immediate life threatening diseases such as preexisting cardiovascular, liver, or neoplastic diseases or who received any immunosuppressant, sedative, hypnotic or tranquilizer within 14 days prior to enrollment;
3. Individuals with any psychiatric illness which may impair the ability to provide written ICF.
4. Individuals participating in any other clinical trial.
5. Pregnant or lactating females.
6. Alcohol, smoke, and drug abusers will be excluded from study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in NAFLD Score |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Subjective parameters, LFT, USG |
60days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/01/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an open labeled single armed, single centric, prospective interventional clinical study to evaluate the efficacy of Muliv Strong Syrup on 50 patients suffering Non- Alcoholic Fatty Liver disease (NAFLD). The study will be conducted in National Institute of Ayurveda, Jaipur, Rajasthan,
Dose: 10 ml tds Muliv Strong Syrup orally will be given before meal with luke warm water for 45days.
Purpose –
To evaluate the effect of Muliv Strong Syrup in the management of Non- Alcoholic Steatohepatitis (NASH).
Research question: Is Muliv Strong Syrup is effective in management of Non- Alcoholic Fatty Liver disease (NAFLD).
Null Hypothesis: Muliv Strong Syrup is not effective in the management of Non- Alcoholic Fatty Liver disease (NAFLD).
Alternative hypothesis: Muliv Strong Syrup is effective in the management of Non- Alcoholic Fatty Liver disease (NAFLD).
|