The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study

The study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient with written ICF signed
patient with functional dyspepsia diagnosed by the Rome III criteria
age between 18y and 65y;male or female.
patient without gastric ulcers, erosive gastritis or other gastric organic diseases according to the endoscopy in the past one year in the hospital
patient without hepatobiliary and pancreatic diseases according to B-ultrasoundin the past one year in the hospital
patient with normal ECG (QT interval in the normal range) within one month prior to enrollment in this center
patient with symptoms of only one subtype of functional dyspepsia

Exclusion criteria

history of abdominal surgery;
take drugs related to gastrointestinal motility or gastric acid secretion and gastric acid drugs, anti-Helicobacter pylori drugs within 5 days of inclusion
suffering from hepatobiliary and pancreatic diseases with B ultrasound
suffering from high blood pressure and uncontroled hypertension
diabetes mellitus
have history of thyroid disease, systemic sclerosis, systemic lupus erythematosus
severe mental disorders
pregnant women, breastfeeding women or those who plan to become pregnant
allergy to Qizhiweitong particle
have symptoms of both subtypes of functional dyspepsia

Treatment and study plan

Qizhiweitong granule

Drug

Primary outcomes

symptom severity score

Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jun 2, 2015
Registry last updated: Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed