Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Conditions
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Functional Dyspepsia, Traditional Chinese Medicine

Intervention / Treatment
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* Drug: Qizhi Weitong Granules
* Drug: Mosapride Citrate Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qizhi Weitong Granules Group<br>Patients in this group will take Qizhi Weitong Granules for 8 weeks. | Drug: Qizhi Weitong Granules<br>* Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.<br>* Other names: The Treatment Group;|
| Active Comparator: Mosapride Citrate Tablets Group<br>Patients in this group will take mosapride citrate tablets for 8 weeks. | Drug: Mosapride Citrate Tablets<br>* Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.<br>* Other names: The Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The score will be assessed at baseline and 2 week, 4 week, 6 week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale | To evaluate the changes of patients' mental and psychological status | The score will be assessed at baseline and 2 week, 4 week, 6 week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia, Qizhi Weitong Granules, Traditional Chinese Medicine