Heweizhixie capsuleTherapy on Patients With Diarrhea | NCT02607176

Studies
Heweizhixie capsuleTherapy on Patients With Diarrhea

NCT02607176

Sponsor

Shanghai University of Traditional Chinese Medicine

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

2,400Actual

Phase

Phase 4

Conditions

Diarrhea

Interventions

Heweizhixie capsule

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2017Actual

Completion Date

Apr 2018Actual

First Submitted Date

Nov 14, 2015

First Submission Date that Met QC Criteria

Nov 14, 2015

First Posted Date

Nov 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2019

Last Update Posted Date

Jul 5, 2019Actual

Name	Class
Longhua Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heweizhixie capsule	Experimental	Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral	Drug: Heweizhixie capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heweizhixie capsule	Drug	3 #, Tid, Oral for 3 days	Heweizhixie capsule

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
QingShan Zheng, Dr	Shanghai University of Chinese Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long hua hospital		Shanghai		200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided