55
Participants
Start Date
December 15, 2023
Primary Completion Date
May 17, 2024
Study Completion Date
August 28, 2024
Sesame Oil (SO) at 100 mg/mL in dissolving fluid.
Pure Sesamum indicum oil (cold-pressed, unrefined) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by homogenization (30 min, 37°C). Used as monotherapy.
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
Pure Olea europaea oil (first cold-pressed, acidity ≤0.8%) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by vortex mixing (15 min, 25°C). Used as monotherapy.
50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).
A 1:1 (v/v) blend of Sesamum indicum oil (AIU-BC-618-1) and Olea europaea oil (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by mechanical stirring (1 hr, 40°C).
50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).
50% Plantago ovata mucilage extract (aqueous extraction, 65°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by sonication (20 min).
Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3
50% Taraxacum officinale root extract (ethanol-water extraction, 70°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by magnetic stirring (30 min, 50°C).
50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).
25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).
Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.
25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).
Arab International University, Damascus
University of Duhok
OTHER