Status:
UNKNOWN
The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of the study is to reduce the severity and duration of acute attacks, to prevent the recurrence of new acute attacks and to improve patient's quality of life. Coltect contains anti inflammato...
Detailed Description
Studies in animal models of colitis and in humans with IBD demonstrated that the components of Coltect have anti-inflammatory effects: Hanai H. et al demonstrated that curcumin was safe and effective...
Eligibility Criteria
Inclusion
- Age 18-75 years old.
- Subjects with mild to moderate active ulcerative colitis
- Hemoglobin value greater than 10 g/dL.
- Aspartate aminotransferase and alanine aminotransferase \<1.5 times the upper limit of normal.
- Serum bilirubin and creatinine \<1.5 × upper limit of normal.
- Subjects that provided informed consent and agree to comply with all study procedure.
- Subjects had a Clinical Activity Index (CAI) \>4
- Subjects had a Clinical Activity Index (CAI) ≤8
- Established or new diagnosis.
- Subjects that agreed to undergo sigmoidoscopy at study completion
Exclusion
- Active chronic inflammatory or autoimmune disease other than UC.
- Active infection, including viral infection.
- Active peptic ulcer disease.
- Infectious/ Ischemic colitis.
- Acute or chronic cardiac, renal failure (serum creatinine \>300 mmol/L)
- Abnormal liver function - (liver function tests greater than 1.5 times upper range of normal).
- Crohn's disease.
- Use of rectal corticosteroids within 4 weeks before study entry.
- Patients with known or suspected bleeding tendency.
- Patients with severe active ulcerative colitis.
- Present or a history of colorectal cancer.
- Serious other disease(s) that according to physicians judgment should preclude the patient from participation in the study.
- Toxic megacolon.
- Prior bowel resection.
- Baseline positive stool culture or C DIFF toxin assay.
- Existing or intended pregnancy.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00793130
Start Date
November 1 2008
End Date
November 1 2009
Last Update
November 19 2008
Active Locations (1)
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1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Gush-Dan, Israel, 64239