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 because the information has not been verified recently.
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00793130
First received: November 16, 2008
Last updated: November 18, 2008
Last verified: November 2008
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 16, 2008
Last Updated: November 18, 2008
Health Authority: Israel: Ministry of Health
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Tel-Aviv Sourasky Medical Center:
Ulcerative
Colitis
Coltect
Curcumin
Green tea
Selenium
inflammation
bowel

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014