Heweizhixie capsuleTherapy on Patients With Diarrhea
Heweizhixie capsuleTherapy on Patients With Diarrhea
The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in
 patients with diarrhea.
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.
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.