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

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ClinicalTrials.gov Identifier: NCT02460601
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Zhongcheng Duan, 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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Qizhiweitong granule Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Qizhiweitong granule
2.5g/time,tid,oral administration,6 weeks
Drug: Qizhiweitong granule
Placebo Comparator: Placebo
2.5g/time,tid,oral administration,6 weeks
Drug: Qizhiweitong granule



Primary Outcome Measures :
  1. symptom severity score [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhongcheng Duan, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02460601     History of Changes
Other Study ID Numbers: LCMSBL-09006
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms