RecruitingPhase 3NCT06696261

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).

Sponsor

Tasly Pharmaceutical Group Co., Ltd

Enrollment

342 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Postprandial Distress Syndrome

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lianxiaxiaopi Granules and a drug called a simulated agent of Lianxiaxiaopi Granules for people with postprandial distress syndrome. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLianxiaxiaopi Granules

The participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.

DRUGa simulated agent of Lianxiaxiaopi Granules

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

Locations(18)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, China

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, China

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Xingtai Medical College

Xingtai, Hebei, China

Baoding No. 1 Hospital of Traditional Chinese Medicine

Baoding, Heibei, China

The First People's Hospital of Luoyang City

Luoyang, Henan, China

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, China

General Hospital of the Northern Theater of the Chinese People's Liberation Army

Shenyang, Liaoning, China

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Xianyang, Shanxi, China

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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