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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522093
Enrollment
60
Registered
2007-08-29
Start date
2007-08-31
Completion date
2008-03-31
Last updated
2011-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation

Keywords

constipation

Brief summary

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.

Interventions

DRUGTJ-100

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

Sponsors

Tsumura USA
CollaboratorINDUSTRY
Showa Inan General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse eventsbaseline (4 weeks)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026