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Heweizhixie capsuleTherapy on Patients With Diarrhea

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ClinicalTrials.gov Identifier: NCT02607176
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Longhua Hospital
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Study Description
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Brief Summary:
The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Heweizhixie capsule Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Heweizhixie capsule
Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral
 Drug: Heweizhixie capsule
3 #, Tid, Oral for 3 days
Other Name: Changdaoqing capsule


Outcome Measures
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Primary Outcome Measures :
  1. Percent of subjects with treatment Success [ Time Frame: 3 days ]
    Percent of subjects with treatment Success


Secondary Outcome Measures :
  1. Number of unformed stools passed per 24 h period [ Time Frame: per 24 h period ]
    Number of unformed stools passed per 24 h period

  2. Time (hours) from first intake to the last unformed stools [ Time Frame: 3 days ]
    Time (hours) from first intake to the last unformed stools

  3. Change from baseline of leeds dyspepsia questionnaire score [ Time Frame: 3 days ]
    Change from baseline of leeds dyspepsia questionnaire score

  4. Percent of subjects with AE [ Time Frame: 3 days ]
    Percent of subjects with AE


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607176


Locations
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China
Long hua hospital
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Longhua Hospital
Investigators
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Study Chair: QingShan Zheng, Dr Shanghai University of Chinese Medicine
More Information
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02607176    
Other Study ID Numbers: ZY3-CCCX-3-1001
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive