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OpenTrials
Completed

NCT Number: NCT00522093

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

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.

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Key information

Conditions

Chronic Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General Hospital

Komagane, 399-4191, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TJ-100

Drug

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

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

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Collaborators

  • Tsumura USA

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2007
Registry last updated
Aug 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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