Heweizhixie capsuleTherapy on Patients With Diarrhea

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Phase 4

Conditions: Diarrhea

Treatments: Drug: Heweizhixie capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02607176

ZY3-CCCX-3-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,400 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,400 participants in 1 patient group

Heweizhixie capsule

Experimental group

Description:

Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral

Treatment:

Drug: Heweizhixie capsule