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

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ClinicalTrials.gov 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
Sponsor:
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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

Drug Information available for: Curcumin

Arm Intervention/treatment
Coltect
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00793130


Contacts
Contact: Iris Dotan, MD +972-3-6947305 irisd@tasmc.health.gov.il
Contact: Nadir Arber, MD +972-3-6974968 nadir@tasmc.health.gov.il

Locations
Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Gush-Dan, Israel, 64239
Contact: Iris Dotan, MD    +972-3-6947305    irisd@tasmc.health.gov.il   
Contact: Nadir Arber, MD    +972-3-6974968    nadir@tasmc.health.gov.il   
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

Responsible Party: Dr. Iris Dotan, Department of Gastroenterology and Liver Diseases
ClinicalTrials.gov Identifier: NCT00793130     History of Changes
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:
Ulcerative
Colitis
Coltect
Curcumin
Green tea
Selenium
inflammation
bowel

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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