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

N/ACompletedNCT00522093

Showa Inan General Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Constipation

Interventions

TJ-100DRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Showa Inan General Hospital

Komagane, Japan

Outcomes

Primary Outcomes

Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events

Time frame: baseline (4 weeks)

Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events

Time frame: 6 weeks

Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events

Time frame: 2 weeks

Data from ClinicalTrials.gov

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