Heweizhixie capsuleTherapy on Patients With Diarrhea

Phase 4

Completed

• Conditions: Diarrhea
• Interventions: Drug: Heweizhixie capsule

• Registration Number: NCT02607176
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-14
• Study First Submitted QC: 2015-11-14
• Study First Posted: 2015-11-17
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

3 or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent

Exclusion Criteria

Subjects with serum ALT more than 5ULN or serum Cr more than 442umol/L Subjects are pregnant now, likely to become pregnant Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heweizhixie capsule	Heweizhixie capsule	Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral

Primary Outcome Measures

Name	Time	Method
Percent of subjects with treatment Success	3 days	Percent of subjects with treatment Success

Secondary Outcome Measures

Name	Time	Method
Percent of subjects with AE	3 days	Percent of subjects with AE
Number of unformed stools passed per 24 h period	per 24 h period	Number of unformed stools passed per 24 h period
Time (hours) from first intake to the last unformed stools	3 days	Time (hours) from first intake to the last unformed stools
Change from baseline of leeds dyspepsia questionnaire score	3 days	Change from baseline of leeds dyspepsia questionnaire score

Trial Locations

Locations (1)

Long hua hospital; 🇨🇳 Shanghai, China