Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Phase 1

• Conditions: Functional Dyspepsia; Traditional Chinese Medicine
• Interventions: Drug: Qizhi Weitong Granules; Drug: Mosapride Citrate Tablets

• Registration Number: NCT03149393
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-04-16
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qizhi Weitong Granules Group	Qizhi Weitong Granules	Patients in this group will take Qizhi Weitong Granules for 8 weeks.
Mosapride Citrate Tablets Group	Mosapride Citrate Tablets	Patients in this group will take mosapride citrate tablets for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change of Main Symptom Score	The score will be assessed at baseline and 2 week, 4 week, 6 week.	The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.

Secondary Outcome Measures

Name	Time	Method
Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale	The score will be assessed at baseline and 2 week, 4 week, 6 week.	To evaluate the changes of patients' mental and psychological status

Trial Locations

Locations (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China