Date

2022-10-24

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

1. Volunteers with a history of chronic illness such as diabetes mellitus, hypertension, cardiovascular diseases, chronic liver and kidney disease, and any other disease that warrants long term medication (e.g., autoimmune disease); 2. Volunteers who have abnormal baseline investigations by history, examination, systolic and diastolic blood pressure, and those who have abnormal 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 would be excluded from the trial; 3. Volunteers on any medicines, including nutritional, Ayurveda/ herbal supplements; 4. Married women volunteers and any women planning to get married during the 4 months after recruitment to the study; 5. Allergies or allergic reactions to any of the ingredients of LLC.

Next Version

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