NCT01232114

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
Last Updated

November 2, 2010

Status Verified

October 1, 2010

Enrollment Period

Same day

First QC Date

October 19, 2010

Last Update Submit

November 1, 2010

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

    14 days

Secondary Outcomes (1)

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

    30 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with functional dyspepsia primary care clinic were studied

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan university of TCM

Changsha, Hunan, 410007, China

RECRUITING

Study Officials

  • Liu b yan, doctor

    Hunan university of TCM

    STUDY DIRECTOR

Central Study Contacts

Cai g xian, Master

CONTACT

8673188458001lby1203@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2010

First Posted

November 2, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 2, 2010

Record last verified: 2010-10

Locations

CN(1)