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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02607176

Enrollment

2400

Registered

2015-11-17

Start date

2015-10-31

Completion date

2018-04-30

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea

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.

Interventions

DRUGHeweizhixie capsule

3 #, Tid, Oral for 3 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Percent of subjects with treatment Success	3 days	Percent of subjects with treatment Success

Secondary

Measure	Time frame	Description
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
Percent of subjects with AE	3 days	Percent of subjects with AE

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026