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The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00793130
Recruitment Status : Unknown
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : November 19, 2008
Last Update Posted : November 19, 2008
Information provided by:
Tel-Aviv Sourasky Medical Center

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 inflammatory and antioxidant natural agents (curcumin, green tea and selenomethionine) which are associated with a positive effect on inflammatory disease.

The investigators assume that Coltect represents a tolerable and mild treatment, viable alternative to other medical therapies with fewer side effects.

Coltect is a food supplement that contains active ingredients from herbal sources.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Coltect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label
Study Start Date : November 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Coltect contains natural compounds: curcumin, green tea and selenium which are approved as food supplements by the Ministry of Health in Israel. Curcumin and green tea are widely used in the food industry.
Dietary Supplement: Coltect
Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.

Primary Outcome Measures :
  1. 50% improvement of the Clinical Activity Index (CAI) of the study. [ Time Frame: 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00793130

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Contact: Iris Dotan, MD +972-3-6947305
Contact: Nadir Arber, MD +972-3-6974968

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Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Gush-Dan, Israel, 64239
Contact: Iris Dotan, MD    +972-3-6947305   
Contact: Nadir Arber, MD    +972-3-6974968   
Principal Investigator: Iris Dotan, MD         
Sub-Investigator: Nadir Arber, MD         
Sub-Investigator: Aharon Hallak, MD         
Sub-Investigator: Sigal Fishman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Responsible Party: Dr. Iris Dotan, Department of Gastroenterology and Liver Diseases Identifier: NCT00793130    
Other Study ID Numbers: TASMC-08-ID-348-CTIL
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Keywords provided by Tel-Aviv Sourasky Medical Center:
Green tea
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases