Date

2025-09-30

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Setting: The study will be conducted at the liver clinic of Colombo North Teaching Hospital, Ragama. The study will recruit consenting patients diagnosed with MAFLD who fulfill the specified inclusion and exclusion criteria of the trial. The patients that are excluded will receive standard care provided by the liver clinic of Colombo North Teaching Hospital, Ragama. Enrollment: Advertisement about the details of the study and contact number of PI will display in three language (Sinhala/English/Tamil) at the Liver Clinic at Colombo North Teaching Hospital, Ragama. Interesting participants will contact PI and they will be approached by a trained medically qualified research assistant who has completed GCP training. Randomization: Simple randomization method using computer-generated random numbers. The patients will be randomized in a 1:1:1 ratio. Blinding: Neither participants, nor investigators, nor data collectors nor the study team nor data analysts will be aware of treatment assignments prior to the final breaking of codes of database. The codes of database will be opened after completion of the data analysis and conclusion of the study. Intervention: The LLC and placebo tablets will be manufactured in identical shape and size and will be film coated to give the same appearance. Both LLC tablets and placebo tablets will be packed into identical white HDPE (High Density Polyethylene) plastic bottles numbered from 1 to 294 by a senior R&D Scientist (Pharmacist) at Link Natural Products (Pvt.) Ltd. according to the list of computer-generated random numbers. The label of each bottle will indicate only the patient’s random number and the directions for taking the tablets. Each bottle contains medication/ placebo required for 30 days. Dosage form of LLC and placebo is a tablet. Patients will be asked to take the medication as one tablet (Low dose group) or two tablets (High dose group) every day after the dinner. The duration of the study is 12 months. LLC tablet comprises of fourteen herbal ingredients namely Andrographis paniculata, Eclipta prostrata, Phyllanthus amarus, Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Tinospora cordifolia, Curcuma longa, Glycyrrhiza glabra, Boerhavia diffusa, Osbeckia octandra, Tephrosia purpurea, Piper longum and Cyanthillium cinereum. The placebo tablet comprises, microcrystalline cellulose BP., maize starch BP., sodium starch glycolate BP., carboxymethyl cellulose BP., Aerosil 200 Pharma., and magnesium stearate BP [All excipients in the investigational medicine other than the active ingredient is included].

Next Version

Setting: The study will be conducted at the Department of Gastroenterology and Hepatology, National Hospital of Sri Lanka, Colombo. The study will recruit consenting patients diagnosed with MAFLD who fulfill the specified inclusion and exclusion criteria of the trial. The patients that are excluded will receive standard care provided by the Department of Gastroenterology and Hepatology, National Hospital of Sri Lanka, Colombo. Enrollment: Advertisement about the details of the study and contact number of PI will display in three language (Sinhala/English/Tamil) at the Department of Gastroenterology and Hepatology, National Hospital of Sri Lanka, Colombo. Interesting participants will contact PI and they will be approached by a trained medically qualified research assistant who has completed GCP training.