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CompletedNCT00522093Updated Aug 23, 2011

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

An interventional study of TJ-100 in Chronic Constipation, sponsored by Showa Inan General Hospital. Completed at 1 site in Japan. Open to participants aged 20 Years to 89 Years. Per ClinicalTrials.gov, last updated 2011-08-23.

Sponsored by Showa Inan General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Constipation

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Keywords

  • constipation
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Showa Inan General Hospital is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • mechanical bowel obstruction
  • clinically systemic disease-induced constipation
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • DrugTJ-100

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

06

What researchers measure

Primary outcomes

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

    Time frame: baseline (4 weeks)

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

    Time frame: 6 weeks

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

    Time frame: 2 weeks

07

Study locations

1 site
  • Showa Inan General Hospital
    Komagane, 399-4191, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00522093
Lead sponsor
Showa Inan General Hospital
Collaborators
Tsumura USA
Responsible party
Akira Horiuchi (Digestive Disease Center, Showa Inan General Hospital) — Principal investigator
First posted
Aug 29, 2007
Start date
Aug 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Aug 23, 2011

Study contacts

Akira Horiuchi, M.D.
principal investigator · Showa Inan General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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