Functional Dyspepsia(FD) Was StudiedSMTNCT01232114
Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia
An observational study of Functional Dyspepsia(FD) Was Studied and Effect of Simotang on FD Was Studied, run by Hunan University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia(FD) Was Studied, Effect of Simotang on FD Was Studied
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with functional dyspepsia primary care clinic were studied
Who may be able to join
- patients met the definition of the Rome III criteria for FD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan university of TCM
Changsha, Hunan, 410007
Yi jian, master, 8673185381065, yijian556@126.com
About this study
Official 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety
Measured: 14 days
Secondary outcomes (1)
Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2010
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Dyspepsia(FD) Was StudiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Liu b yan, doctor, Study director, Hunan university of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232114
- Sponsor's protocol ID
- CB523002
- Acronym
- SMT
- Status last verified
- Oct 2010
- First submitted
- 19 Oct 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01232114
- Acronym / sponsor ID
- SMT / CB523002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (estimated)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with functional dyspepsia primary care clinic were studied
Key inclusion criteria (1 listed)
- patients met the definition of the Rome III criteria for FD
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety
Time frame: 14 days
1 secondary outcome
Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
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Enrolling by invitation
To Observe the Clinical Efficacy of Traditional Chinese Medicine Compound(Weipi Formula ) in the Treatment of Epigastric Stuffiness Syndrome
Functional Dyspepsia(FD) Was Studied
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu b yan, doctor study director
Hunan university of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia(FD) Was Studied and Effect of Simotang on FD Was Studied, run by Hunan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cai g xian, Master (8673188458001, lby1203@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2010.