The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study

Huazhong University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Functional Dyspepsia

Treatments: Drug: Qizhiweitong granule

Study type: Interventional

Funder types: Other

Identifiers

NCT02460601

LCMSBL-09006

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Qizhiweitong granule

Experimental group

Description:

2.5g/time,tid,oral administration,6 weeks

Treatment:

Drug: Qizhiweitong granule

Placebo

Placebo Comparator group

Description:

2.5g/time,tid,oral administration,6 weeks

Treatment:

Drug: Qizhiweitong granule