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

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

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Drug: Heweizhixie capsule

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 Type: Interventional
• Enrollment (Actual): 2400
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Long hua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heweizhixie capsule; Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral	Drug: Heweizhixie capsule; 3 #, Tid, Oral for 3 days; Other Names: Changdaoqing capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of subjects with treatment Success	Percent of subjects with treatment Success	3 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Longhua Hospital
• Investigators: Study Chair: QingShan Zheng, Dr, Shanghai University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: November 14, 2015
• First Submitted That Met QC Criteria: November 14, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: ZY3-CCCX-3-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO