A 12-Week Randomized, Double-Blind Study to Test the Safety and Effectiveness of Extract of Dolichos lablab Linne EDL for Adults with Functional Dyspepsia

What this Trial Is About

Researchers are investigating the effects of Extract of Dolichos lablab Linne EDL on adults who experience functional dyspepsia, a common digestive disorder that can cause persistent discomfort and lower quality of life. The study aims to compare the functional and safety effects of EDL against a placebo in relieving dyspeptic symptoms. This trial is randomized, double-blind, and placebo-controlled, focusing on adults diagnosed with functional dyspepsia according to specific diagnostic criteria. Participants are randomly assigned to receive either 715 mg per day of EDL or a placebo for 12 weeks. The investigational product is taken orally once daily as two tablets. The study monitors symptoms and safety outcomes throughout the 12-week treatment period to assess the impact of EDL compared to placebo. During the study, participants will be evaluated using the Gastrointestinal Symptom Rating Scale GSRS for stomach symptoms at 6 and 12 weeks, along with other assessments such as the Gastrointestinal Symptom questionnaire, Functional Dyspepsia-Related Quality of Life, and various blood markers. The research team also tracks inflammatory and antioxidant markers to understand safety and physiological effects. Overall participation includes initial screening, 12 weeks of treatment, and regular symptom and safety assessments.

Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia