Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Functional Dyspepsia; Traditional Chinese Medicine

Treatments: Drug: Mosapride Citrate Tablets; Drug: Qizhi Weitong Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT03149393

Digestion-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 384 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

384 participants in 2 patient groups

Qizhi Weitong Granules Group

Experimental group

Description:

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

Treatment:

Drug: Qizhi Weitong Granules

Mosapride Citrate Tablets Group

Active Comparator group

Description:

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

Treatment:

Drug: Mosapride Citrate Tablets