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

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Qizhiweitong granule
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Qizhiweitong granule

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    symptom severity score

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2015
    Last Updated
    December 8, 2015
    Sponsor
    Wuhan Union Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460601
    Brief Title
    The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wuhan Union Hospital, China

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Dyspepsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Qizhiweitong granule
    Arm Type
    Experimental
    Arm Description
    2.5g/time,tid,oral administration,6 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    2.5g/time,tid,oral administration,6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Qizhiweitong granule
    Primary Outcome Measure Information:
    Title
    symptom severity score
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient with written ICF signed patient with functional dyspepsia diagnosed by the Rome III criteria age between 18y and 65y;male or female. patient without gastric ulcers, erosive gastritis or other gastric organic diseases according to the endoscopy in the past one year in the hospital patient without hepatobiliary and pancreatic diseases according to B-ultrasoundin the past one year in the hospital patient with normal ECG (QT interval in the normal range) within one month prior to enrollment in this center patient with symptoms of only one subtype of functional dyspepsia Exclusion Criteria: history of abdominal surgery; take drugs related to gastrointestinal motility or gastric acid secretion and gastric acid drugs, anti-Helicobacter pylori drugs within 5 days of inclusion suffering from hepatobiliary and pancreatic diseases with B ultrasound suffering from high blood pressure and uncontroled hypertension diabetes mellitus have history of thyroid disease, systemic sclerosis, systemic lupus erythematosus severe mental disorders pregnant women, breastfeeding women or those who plan to become pregnant allergy to Qizhiweitong particle have symptoms of both subtypes of functional dyspepsia

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29941708
    Citation
    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.
    Results Reference
    derived

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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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