Health Condition 1: null- NAFLD patients with diabetes, obesity and hyper-lipidemia as co-morbid conditions.
Conditions
Interventions
Intervention1: AML5HS AMLA extract: AML5HS AMLA 500 mg per capsule. 2 capsules twice a day for a period of 90 ± 7 days
Control Intervention1: Placebo: Placebo contains Inactive ingredients. 2 capsu
Sponsors
Acara Bioherb Pvt Ltd
Acara Bioherb Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in body weight and body mass index Decrease in waist circumference and waist: hip ratio (anthropometric measurements)Timepoint: 0 day Day 30 Day 60 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Cholesterol, Triglycerides, LDL and VLDL values from baseline, if any Change in HDL values from baseline, if any Photographs of the subjects on baseline and on last visit while concealing his/her identityTimepoint: 0 day Day 30 Day 60 Day 90 | — |
Countries
India
Contacts
Public ContactDr Ashok
Radiant Research Services
Outcome results
None listed