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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

Tracking Information
First Submitted Date  ICMJE May 28, 2015
First Posted Date  ICMJE June 2, 2015
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
symptom severity score [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02460601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Functional Dyspepsia
Intervention  ICMJE Drug: Qizhiweitong granule
Study Arms  ICMJE
  • Experimental: Qizhiweitong granule
    2.5g/time,tid,oral administration,6 weeks
    Intervention: Drug: Qizhiweitong granule
  • Placebo Comparator: Placebo
    2.5g/time,tid,oral administration,6 weeks
    Intervention: Drug: Qizhiweitong granule
Publications * Su Q, Chen SL, Wang HH, Liang LX, Dai N, Lyu B, Zhang J, Wang RQ, Zhang YL, Yu Y, Liu JS, Hou XH. A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia. Chin Med J (Engl). 2018 Jul 5;131(13):1549-1556. doi: 10.4103/0366-6999.235118. Erratum in: Chin Med J (Engl). 2019 Jan 20;132(2):249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2015)
400
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02460601
Other Study ID Numbers  ICMJE LCMSBL-09006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhongcheng Duan, Wuhan Union Hospital, China
Study Sponsor  ICMJE Wuhan Union Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wuhan Union Hospital, China
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP