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

Phase 4

Completed

• Conditions: Functional Dyspepsia
• Interventions: Drug: Qizhiweitong granule

• Registration Number: NCT02460601
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-02
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qizhiweitong granule	Qizhiweitong granule	2.5g/time,tid,oral administration,6 weeks
Placebo	Qizhiweitong granule	2.5g/time,tid,oral administration,6 weeks

Primary Outcome Measures

Name	Time	Method
symptom severity score	3 days