Health Condition 1: K758- Other specified inflammatory liverdiseases
Conditions
Interventions
Intervention1: Saberry®: One capsule once a day for a period of 90 days.
Control Intervention1: NIL: NIL
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Complete Liver Profile 2 Anti oxidant enzymes 3 Haematology for immuno stimulation 4 Complete Lipid Profile 5 Glycaemic Profile 6 Chronic Liver Disease QuestionnaireTimepoint: 1 Complete Liver Profile 2 Anti oxidant enzymes 3 Haematology for immuno stimulation 4 Complete Lipid Profile 5 Glycaemic Profile 6 Chronic Liver Disease Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse events 2 Abnormal vital signsTimepoint: 1 Adverse events[Day 30,Day 60 & Day 90] 2 Abnormal vital signs[Screening, Day 0,Day 30,Day 60 & Day 90] | — |
Countries
India
Contacts
Public ContactMr Hasan Ahmed
ClinWorld Private Limited
Outcome results
None listed