A clinical study to evaluate the effect of two herbal drugs, bhunimba kshara and katuki churna in combination with restricted diet, exercise and yoga in patients of Non- alcoholic fatty liver disease.

Phase 2/3

Recruiting

Conditions: Fatty (change of) liver, not elsewhere classified,

Registration Number: CTRI/2019/03/018039

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: This study is a double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba kshara capsule, 125mg twice daily and katuki churna 1g bedtime along with modification of lifestyle for a period of one month in the patients of Non alcoholic liver diseases. Over the past couple of decades, it has become increasingly clear that non alcoholic fatty liver disease (NAFLD) and non-alcoholic steato-hepatitis (NASH) are the significant causes of liver disease. NAFLD also called as hepatic steatosis is a manifestation of excessive triglycerides accumulation in the liver. Improper diet, lack of exercise and unhealthy lifestyle are the leading cause of this. The aim of the study to evaluate the efficacy of bhunimba kshara and katuki churna for reversing the fatty degeneration and preventing the progression of the condition to further complications like hepato cellular carcinoma and liver cirrhosis etc. The primary outcome measures the changes in the fatty degeneration of hepatic cells which will be assessed by using ultrasonography. The secondary outcome is that the intervention will help to normalize the liver function tests and cure of the symptoms in NAFLD patients. Placebo drugs will be given the control group along with the modification of lifestyle. The subjects for the study will be selected from the OPD and IPD of All India Institute of Ayurveda , New Delhi and the follow up should be done on zero, fifteenth, thirteith and sixteith day of patient enrollement.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 30

Inclusion Criteria

Non-alcoholic fatty liver disease patient who diagnosed by abdomen ultrasonic examination and Non-drinker Or total abstainer or with alcohol intake of less than 20g per day for female and less than 30 g per day for males NAFLD confirmed by USG with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen 3.
Voluntary agreement and enrolment.

Exclusion Criteria

The ratio of AST and ALT over 2 Metabolic syndromes such as Type I and II diabetes mellitus hypertension Thyroid dysfunctions hypothyroidism or hyperthyroidism Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months Patient taking any product which affects the BMI or hyperlipidemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the infiltration of fat globules in Ultrasonography (USG) findings along with changes in clinical presentations	Zero \| Thirteith day

Secondary Outcome Measures

Name	Time	Method
Liver function tests	Lipid profile

Trial Locations

Locations (1): New Delhi
🇮🇳
South, DELHI, India
New Delhi
🇮🇳South, DELHI, India
Dr Shinsha P
Principal investigator
8851003340
shinshasivadasan@gmail.com