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Completed

NCT Number: NCT02607176

Heweizhixie capsuleTherapy on Patients With Diarrhea

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

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Long hua hospital

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heweizhixie capsule

Drug

3 #, Tid, Oral for 3 days

Other names: Changdaoqing capsule

Primary outcomes

  1. Percent of subjects with treatment Success

    Time frame: 3 days

    Percent of subjects with treatment Success

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Longhua Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 17, 2015
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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