Clinical evaluation for the efficacy of Muliv strong syrup in the management of Non- Alcoholic Fatty Liver disease (NAFLD).

Phase 2

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** â€“

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).

Recruitment & Eligibility

Inclusion Criteria

Patients of either sex not taking any medicine will be included in the study.
Individuals suffering from NAFLD with or without elevated liver enzymes or hepatomegaly will be included.
Patients willing to give informed consent for the study.

Exclusion Criteria

Individuals with chronic hepatitis (more than 3 months), Patients with malignant jaundice, patient with acute hepatitis (Other than infective).
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.
Individuals participating in any other clinical trial.
Pregnant or lactating females.
Alcohol, smoke, and drug abusers will be excluded from study.

Primary Outcome Measures

Name	Time	Method
Changes in NAFLD Score	60 days

Secondary Outcome Measures

Name	Time	Method
Changes in Subjective parameters, LFT, USG	60days

Locations (1): National Institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Gopesh Mangal
Principal investigator
8619849011
gmangal108@gmail.com