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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: November 16, 2008
Last updated: November 18, 2008
Last verified: November 2008

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 Intervention
Ulcerative Colitis Dietary Supplement: Coltect

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00793130

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

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
  More Information

Responsible Party: Dr. Iris Dotan, Department of Gastroenterology and Liver Diseases Identifier: NCT00793130     History of Changes
Other Study ID Numbers: TASMC-08-ID-348-CTIL
Study First Received: November 16, 2008
Last Updated: November 18, 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
Green tea

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017