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Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Primary Purpose

Functional Dyspepsia, Traditional Chinese Medicine

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Qizhi Weitong Granules
Mosapride Citrate Tablets
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Qizhi Weitong Granules, Traditional Chinese Medicine

Eligibility Criteria

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

Inclusion Criteria:

  1. Metting the diagnostic criteria of functional dyspepsia in Rome IV.
  2. The subjects were informed, and the subjects voluntarily signed informed consent.
  3. The subjects have reading ability.

Exclusion Criteria:

  1. Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
  2. Patients with Hp infection positive.
  3. Patients with gastroesophageal reflux disease.
  4. Patients with digestive system organic lesions.
  5. The patient had a history of stomach or abdominal surgery.
  6. Patients had taken the relevant drugs in the past 2 weeks.
  7. Patients suffering from severe illness affecting survival.
  8. Pregnant or lactating women.
  9. Participating in clinical trials of other drugs.
  10. Long term using of sedative hypnotics.
  11. Suspected or true alcohol, drug abuse history.

Sites / Locations

  • Xiyuan Hospital, China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qizhi Weitong Granules Group

Mosapride Citrate Tablets Group

Arm Description

Patients in this group will take Qizhi Weitong Granules for 8 weeks.

Patients in this group will take mosapride citrate tablets for 8 weeks.

Outcomes

Primary Outcome Measures

Change of Main Symptom Score
The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.

Secondary Outcome Measures

Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale
To evaluate the changes of patients' mental and psychological status

Full Information

First Posted
April 16, 2017
Last Updated
February 26, 2020
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03149393
Brief Title
Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
Official Title
Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.
Detailed Description
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Traditional Chinese Medicine
Keywords
Functional Dyspepsia, Qizhi Weitong Granules, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qizhi Weitong Granules Group
Arm Type
Experimental
Arm Description
Patients in this group will take Qizhi Weitong Granules for 8 weeks.
Arm Title
Mosapride Citrate Tablets Group
Arm Type
Active Comparator
Arm Description
Patients in this group will take mosapride citrate tablets for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Qizhi Weitong Granules
Other Intervention Name(s)
The Treatment Group
Intervention Description
Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Mosapride Citrate Tablets
Other Intervention Name(s)
The Control Group
Intervention Description
Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.
Primary Outcome Measure Information:
Title
Change of Main Symptom Score
Description
The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.
Time Frame
The score will be assessed at baseline and 2 week, 4 week, 6 week.
Secondary Outcome Measure Information:
Title
Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale
Description
To evaluate the changes of patients' mental and psychological status
Time Frame
The score will be assessed at baseline and 2 week, 4 week, 6 week.

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: Metting the diagnostic criteria of functional dyspepsia in Rome IV. The subjects were informed, and the subjects voluntarily signed informed consent. The subjects have reading ability. Exclusion Criteria: Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia. Patients with Hp infection positive. Patients with gastroesophageal reflux disease. Patients with digestive system organic lesions. The patient had a history of stomach or abdominal surgery. Patients had taken the relevant drugs in the past 2 weeks. Patients suffering from severe illness affecting survival. Pregnant or lactating women. Participating in clinical trials of other drugs. Long term using of sedative hypnotics. Suspected or true alcohol, drug abuse history.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang F yun, PhD
Phone
13522657731
Ext
0086
Email
wfy811@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang X dong, PhD
Organizational Affiliation
Director of Xiyuan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xudong Tang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

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