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

Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01232114
Acronym
SMT
Enrollment
400
Registered
2010-11-02
Start date
2010-10-31
Completion date
2010-10-31
Last updated
2010-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Hunan University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety14 days

Secondary

MeasureTime frame
Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy30 days

Countries

China

Contacts

Primary ContactCai g xian, Master
lby1203@sina.com8673188458001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026