Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Hunan University of Traditional Chinese Medicine400 enrolled

Overview

Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily becoming a public health problem.Simotang is a classical formula that has been used to treat gastrointestinal disorders for hundreds of years \[9\] and was approved as an oral liquid drug by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with functional dyspepsia were divided according to the inclusive criteria into treatment group and control group randomly, who were given Simo decoction or Domperidone tablets for 14 days。And then the gastric emptying, Symptoms in plasma were observed before and after treatment in mult-center.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Functional Dyspepsia(FD) Was Studied Effect of Simotang on FD Was Studied

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients met the definition of the Rome III criteria for FD Exclusion Criteria: \-

Locations (1)

Hunan university of TCM

Outcomes

Primary Outcomes

Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety

Time frame: 14 days

Secondary Outcomes

Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy

Time frame: 30 days