This is a single center study wherein the efficacy and safety of Saberry capsules will be studied in adult male or female patients suffering from Non-Alcoholic Fatty Liver Disease.
- Conditions
- Health Condition 1: K758- Other specified inflammatory liverdiseases
- Registration Number
- CTRI/2016/04/006847
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1 Patients of either sex, 20 to 60 years of age.
2 Patients with BMI range 25 to 34 kg/m2
3 Patients with diabetes and hyper lipidemia as co morbid conditions.
4 NAFLD patients who are refractive to standard drugs of treatment.
5 Willing to come for regular follow up visits.
6 CAGE Questionnaire score of 0 to 1.
7 Able to give written informed consent.
1 Known history of hypersensitivity to herbal extracts or dietary supplements.
2 Duration of jaundice greater than 3 months, steato hepatitis, advanced fibrosis, cirrhosis and other liver enzymes.
3 Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.
4 Patients who are on immuno modulatory drugs.
5 Ongoing treatment with herbals or allopathic hepato protective drugs.
6 Evidence of several renal, hepatic or hematopoietic disorders or severe cardiac insufficiency as revealed by laboratory investigations.
7 History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing.
8 Ayurvedic formulation or any form of CAM therapy in the preceding 2 months.
9 Any condition that in the opinion of the investigator does not justify the patients inclusion for the study.
10 Patients who underwent liver transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Complete Liver Profile <br/ ><br>2 Anti oxidant enzymes <br/ ><br>3 Haematology for immuno stimulation <br/ ><br>4 Complete Lipid Profile <br/ ><br>5 Glycaemic Profile <br/ ><br>6 Chronic Liver Disease QuestionnaireTimepoint: 1 Complete Liver Profile <br/ ><br>2 Anti oxidant enzymes <br/ ><br>3 Haematology for immuno stimulation <br/ ><br>4 Complete Lipid Profile <br/ ><br>5 Glycaemic Profile <br/ ><br>6 Chronic Liver Disease Questionnaire
- Secondary Outcome Measures
Name Time Method 1 Adverse events <br/ ><br>2 Abnormal vital signsTimepoint: 1 Adverse events[Day 30,Day 60 & Day 90] <br/ ><br>2 Abnormal vital signs[Screening, Day 0,Day 30,Day 60 & Day 90]