Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation

NCT ID: NCT00522093

Last Updated: 2011-08-23

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-03-31

Brief Summary

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

TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.

Detailed Description

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

Conditions

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

Chronic Constipation

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

TJ-100

TJ-100 2.5g three times per day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
* had symptoms of abdominal bloating or discomfort

Exclusion Criteria

* mechanical bowel obstruction
* clinically systemic disease-induced constipation
* pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tsumura USA

INDUSTRY

Sponsor Role collaborator

Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Akira Horiuchi

Digestive Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Akira Horiuchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Showa Inan General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Showa Inan General Hospital

Komagane, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TJ-100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acupuncture for Chronic Constipation
NCT00746200 COMPLETED PHASE3