Effect of Simotang on FD Was Studied Clinical Trial
— SMTOfficial title:
Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia
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.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - patients met the definition of the Rome III criteria for FD Exclusion Criteria: |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Hunan university of TCM | Changsha | Hunan |
| Lead Sponsor | Collaborator |
|---|---|
| Hunan University of Traditional Chinese Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety | 14 days | Yes | |
| Secondary | Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy | 30 days | No |