Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

NCT03149393 | Unknown Phase 1 DMC

• 1 other identifier: Digestion-05
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Dyspepsia; Traditional Chinese Medicine

Keywords

Functional Dyspepsia; Qizhi Weitong Granules; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Qizhi Weitong Granules Group

EXPERIMENTAL

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

Drug: Qizhi Weitong Granules

Mosapride Citrate Tablets Group

ACTIVE COMPARATOR

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

Drug: Mosapride Citrate Tablets

Interventions

Qizhi Weitong Granules DRUG

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

Also known as: The Treatment Group

Qizhi Weitong Granules Group

Mosapride Citrate Tablets DRUG

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

Also known as: The Control Group

Mosapride Citrate Tablets Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metting the diagnostic criteria of functional dyspepsia in Rome IV.
• The subjects were informed, and the subjects voluntarily signed informed consent.
• The subjects have reading ability.

You may not qualify if:

• Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
• Patients with Hp infection positive.
• Patients with gastroesophageal reflux disease.
• Patients with digestive system organic lesions.
• The patient had a history of stomach or abdominal surgery.
• Patients had taken the relevant drugs in the past 2 weeks.
• Patients suffering from severe illness affecting survival.
• Pregnant or lactating women.
• Participating in clinical trials of other drugs.
• Long term using of sedative hypnotics.
• Suspected or true alcohol, drug abuse history.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

MeSH Terms

Interventions

mosapride

Study Officials

• Tang X dong, PhD

  Director of Xiyuan Hospital

  STUDY DIRECTOR

Central Study Contacts

Wang F yun, PhD

CONTACT

13522657731; wfy811@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: May 11, 2017
• Study Start: February 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)