Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Functional Dyspepsia Clinical Trial

Official title:

Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03149393
• Other study ID #: Digestion-05
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Wang F yun, PhD
• Phone: 13522657731
• Email: wfy811[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Traditional Chinese Medicine

Intervention

Drug:
• Qizhi Weitong Granules
Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.
• Mosapride Citrate Tablets
Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.

Locations

Country	Name	City	State
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.