NCT02607176

Heweizhixie capsuleTherapy on Patients With Diarrhea

A Post -Marketing Drug Evaluation(Phase IV Clinical Trial) to Study the Safety and Efficacy of Heweizhixie Capsule in Patients With Diarrhea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,400 (actual)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.

Detailed description

The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea Primary Outcome Measure:Percent of subjects with treatment Success Secondary Outcome Measures: Number of unformed stools passed per 24 h period Time (hours) from first intake to the last unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of subjects with AE.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Heweizhixie capsule	3 #, Tid, Oral for 3 days

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2015-11-17
• Last updated: 2019-07-05

Locations

1 site across 1 country: China