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

• Conditions: Functional Dyspepsia(FD) Was Studied; Effect of Simotang on FD Was Studied

• Registration Number: NCT01232114
• Lead Sponsor: Hunan University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-11-01
• Last Update Submitted: 2010-11-01
• Study First Posted: 2010-11-02
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients met the definition of the Rome III criteria for FD

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety	14 days

Secondary Outcome Measures

Name	Time	Method
Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy	30 days

Trial Locations

Locations (1)

Hunan university of TCM; 🇨🇳 Changsha, Hunan, China