Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

Last updated: February 26, 2020
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bowel Dysfunction

Colic

Gastroparesis

Treatment

N/A

Clinical Study ID

NCT03149393
Digestion-05
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion,pathological examination showed atrophy of gastric mucosa, intestinal metaplasia ordysplasia.

  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

Total Participants: 384
Study Start date:
February 01, 2017
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing 100091
    China

    Active - Recruiting

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