NCT06696261

A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome

A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled Phase III Clinical Trial on the Efficacy and Safety of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome (Intermingled Cold and Heat).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are: 1. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo. 2. Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome. 3. Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.

Conditions

• Postprandial Distress Syndrome

Interventions

Type	Name	Description
DRUG	Lianxiaxiaopi Granules	The participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.
DRUG	a simulated agent of Lianxiaxiaopi Granules	The participants took orally 1 sachet of simulated agent of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.

Timeline

• Start date: 2025-02-27
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-11-20
• Last updated: 2026-01-20

Locations

18 sites across 1 country: China