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

Chronic Constipation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522093
• Other study ID #: TJ-100
• Status: Completed
• Phase: N/A
• First received: August 27, 2007
• Last updated: August 21, 2011
• Start date: August 2007
• Est. completion date: March 2008

Study information

• Verified date: October 2009
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 89 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

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

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane

Sponsors (2)

Lead Sponsor	Collaborator
Showa Inan General Hospital	Tsumura USA

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events		baseline (4 weeks)	Yes
Primary	Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events		6 weeks	Yes
Primary	Bowel movement frequency, rescue medication use, symptom assessments, bowel gas volume measurement, adverse events		2 weeks	Yes