Back to results

Heweizhixie capsuleTherapy on Patients With Diarrhea

Primary Purpose

Diarrhea

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Heweizhixie capsule

About this trial

This is an interventional treatment trial for Diarrhea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Long hua hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heweizhixie capsule

Arm Description

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

Outcomes

Primary Outcome Measures

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

Full Information

NCT ID

NCT02607176

First Posted

November 14, 2015

Last Updated

July 2, 2019

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02607176

Brief Title

Heweizhixie capsuleTherapy on Patients With Diarrhea

Official Title

A Post -Marketing Drug Evaluation(Phase IV Clinical Trial) to Study the Safety and Efficacy of Heweizhixie Capsule in Patients With Diarrhea

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heweizhixie capsule

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Heweizhixie capsule

Other Intervention Name(s)

Changdaoqing capsule

Intervention Description

3 #, Tid, Oral for 3 days

Primary Outcome Measure Information:

Title

Percent of subjects with treatment Success

Description

Percent of subjects with treatment Success

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Number of unformed stools passed per 24 h period

Description

Number of unformed stools passed per 24 h period

Time Frame

per 24 h period

Title

Time (hours) from first intake to the last unformed stools

Description

Time (hours) from first intake to the last unformed stools

Time Frame

3 days

Title

Change from baseline of leeds dyspepsia questionnaire score

Description

Change from baseline of leeds dyspepsia questionnaire score

Time Frame

3 days

Title

Percent of subjects with AE

Description

Percent of subjects with AE

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

QingShan Zheng, Dr

Organizational Affiliation

Shanghai University of Chinese Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Long hua hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Heweizhixie capsuleTherapy on Patients With Diarrhea

We'll reach out to this number within 24 hrs