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

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460601
• Other study ID #: LCMSBL-09006
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2015
• Last updated: December 8, 2015
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Qizhiweitong granule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom severity score		3 days	No