A double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba Kshara and Katuki Churna along with lifestyle modifications in the management of Non-Alcoholic Fatty Liver disease(NAFLD)
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in the infiltration of fat globules in Ultrasonography (USG) findings along with changes in clinical presentations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
Changes in the infiltration of fat globules in Ultrasonography (USG) findings along with changes in clinical presentations
Time Frame: Zero | Thirteith day
Secondary Outcomes
- Liver function tests(Lipid profile)