The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
NCT ID: NCT02460601
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2013-12-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Qizhiweitong granule
2.5g/time,tid,oral administration,6 weeks
Qizhiweitong granule
Placebo
2.5g/time,tid,oral administration,6 weeks
Qizhiweitong granule
Interventions
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Qizhiweitong granule
Eligibility Criteria
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Inclusion Criteria
2. patient with functional dyspepsia diagnosed by the Rome III criteria
3. age between 18y and 65y;male or female.
4. patient without gastric ulcers, erosive gastritis or other gastric organic diseases according to the endoscopy in the past one year in the hospital
5. patient without hepatobiliary and pancreatic diseases according to B-ultrasoundin the past one year in the hospital
6. patient with normal ECG (QT interval in the normal range) within one month prior to enrollment in this center
7. patient with symptoms of only one subtype of functional dyspepsia
Exclusion Criteria
2. take drugs related to gastrointestinal motility or gastric acid secretion and gastric acid drugs, anti-Helicobacter pylori drugs within 5 days of inclusion
3. suffering from hepatobiliary and pancreatic diseases with B ultrasound
4. suffering from high blood pressure and uncontroled hypertension
5. diabetes mellitus
6. have history of thyroid disease, systemic sclerosis, systemic lupus erythematosus
7. severe mental disorders
8. pregnant women, breastfeeding women or those who plan to become pregnant
9. allergy to Qizhiweitong particle
10. have symptoms of both subtypes of functional dyspepsia
18 Years
65 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Zhongcheng Duan
Professor
References
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Su Q, Chen SL, Wang HH, Liang LX, Dai N, Lyu B, Zhang J, Wang RQ, Zhang YL, Yu Y, Liu JS, Hou XH. A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia. Chin Med J (Engl). 2018 Jul 5;131(13):1549-1556. doi: 10.4103/0366-6999.235118.
Other Identifiers
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LCMSBL-09006
Identifier Type: -
Identifier Source: org_study_id