Date

2022-10-24

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

1. The volunteers provides written informed consent before starting the study; 2. Volunteers who are in the age group 18 years to 60 years, healthy as defined by history, examination and systolic and diastolic blood pressure, and those who have normal baseline investigations, those who have normal liver function (serum bilirubin, AST, ALT, ALP, GGT, Serum albumin, FBS, coagulation tests (PT/INR)), renal function (urine full report, serum creatinine), hematological parameters (FBC, ESR), ultrasound scan of liver and liver fibro scan will be recruited to the study; 3. Both male and unmarried female volunteers will be recruited to the study. Any female volunteer planning to get married during the 4 months after recruitment to the study will excluded from the study.

Next Version

Removal of liver fibro scanner as an investigation to ensure normal liver function in recruiting volunteers EC-21-048: Amended Version – Version 2.2 dated 20th March 2022