Functional Dyspepsia
Conditions
Brief summary
The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.
Interventions
DRUGQizhiweitong granule
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. patient with written ICF signed 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
1. history of abdominal surgery; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom severity score | 3 days |
Outcome results
None listed