Heweizhixie capsuleTherapy on Patients With Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants

NCT01571856

Acute Diarrhea Acute Gastroenteritis

COMPLETED PHASE4

Parasitic Causes of Secretory Diarrhea in Children and Chronically Ill Adult.

NCT03166670

Diarrhea, Secretory

COMPLETED

Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting

NCT00278746

Diarrhea Mortality Hospitalization

COMPLETED NA

Registry and Clinical Observation of Children With Diarrhoeal Disease

NCT05052489

Diarrhea

UNKNOWN

Zinc Dosing Trial - Does Dose Reduction Reduce Side Effects But Retain Efficacy in Diarrhoea Management

NCT03078842

Diarrhea

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heweizhixie capsule

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

Group Type EXPERIMENTAL

Heweizhixie capsule

Intervention Type DRUG

3 #, Tid, Oral for 3 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heweizhixie capsule

3 #, Tid, Oral for 3 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Changdaoqing capsule

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No