Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

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.

Study Overview

• Status: Unknown
• Conditions: Functional Dyspepsia; Traditional Chinese Medicine
• Intervention / Treatment: Drug: Qizhi Weitong Granules; Drug: Mosapride Citrate Tablets

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 Type: Interventional
• Enrollment (Anticipated): 384
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Recruiting
      • Xiyuan Hospital, China Academy of Chinese Medical Sciences
      • Contact: Xudong Tang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Director: Tang X dong, PhD, Director of Xiyuan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 16, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Functional Dyspepsia; Traditional Chinese Medicine; Qizhi Weitong Granules
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Mosapride
• Other Study ID Numbers: Digestion-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No