A study of AMLA extract to assess the antioxidant and rejuvenation potential in adults in a placebo controlled clinical trial.
- Conditions
- Health Condition 1: null- NAFLD patients with diabetes, obesity and hyper-lipidemia as co-morbid conditions.
- Registration Number
- CTRI/2018/08/015157
- Lead Sponsor
- Acara Bioherb Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Patients of either sex, 20 to 60 years of age
Patients with BMI range 20 to 34 kg/m2
Patients with diabetes, obesity and hyper-lipidemia as co-morbid conditions.
NAFLD patients who are refractive to standard drugs of treatment (statins).
Willing to come for regular follow -up visits.
Able to give written informed consent.
Known history of hypersensitivity to herbal extracts or dietary supplements.
Duration of jaundice greater than 3 months, steato-hepatitis, advanced fibrosis, cirrhosis, viral hepatitis and other liver diseases.
Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.
Patients who are on immuno-modulatory drugs.
Ongoing treatment with herbals or allopathic hepato-protective drugs.
Patients on coronary artery disease.
Evidence of several renal, hepatic or hemopoitic disease or severe cardiac insufficiency as revealed by laboratory investigations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method