NCT02607176

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

November 14, 2015

Last Update Submit

July 2, 2019

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Percent of subjects with treatment Success

    Percent of subjects with treatment Success

    3 days

Secondary Outcomes (4)

  • Number of unformed stools passed per 24 h period

    per 24 h period

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

    3 days

  • Change from baseline of leeds dyspepsia questionnaire score

    3 days

  • Percent of subjects with AE

    3 days

Study Arms (1)

Heweizhixie capsule

EXPERIMENTAL

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

Drug: Heweizhixie capsule

Interventions

Heweizhixie capsuleDRUG

3 #, Tid, Oral for 3 days

Also known as: Changdaoqing capsule
Heweizhixie capsule

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long hua hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • QingShan Zheng, Dr

    Shanghai University of Chinese Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2015

First Posted

November 17, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

July 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)