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

NCT02460601 | Completed Phase 4

• 1 other identifier: LCMSBL-09006
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• symptom severity score

  3 days

Study Arms (2)

Qizhiweitong granule

EXPERIMENTAL

2.5g/time,tid,oral administration,6 weeks

Drug: Qizhiweitong granule

Placebo

PLACEBO COMPARATOR

2.5g/time,tid,oral administration,6 weeks

Drug: Qizhiweitong granule

Interventions

Qizhiweitong granule DRUG

Placebo; Qizhiweitong granule

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• history of abdominal surgery;
• 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

Sponsors & Collaborators

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

Related Publications (1)

• Su Q, Chen SL, Wang HH, Liang LX, Dai N, Lyu B, Zhang J, Wang RQ, Zhang YL, Yu Y, Liu JS, Hou XH. A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia. Chin Med J (Engl). 2018 Jul 5;131(13):1549-1556. doi: 10.4103/0366-6999.235118.

  PMID: 29941708 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12