Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03149393

Enrollment

384

Registered

2017-05-11

Start date

2017-02-01

Completion date

2020-12-31

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia, Traditional Chinese Medicine

Keywords

Functional Dyspepsia, Qizhi Weitong Granules, Traditional Chinese Medicine

Brief summary

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.

Interventions

DRUGQizhi Weitong Granules

Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.

DRUGMosapride Citrate Tablets

Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactWang F yun, PhD

wfy811@163.com13522657731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026