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

NCT00793130 | Unknown DMC

• 1 other identifier: TASMC-08-ID-348-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative; Colitis; Coltect; Curcumin; Green tea; Selenium; inflammation; bowel

Outcome Measures

Primary Outcomes (1)

• 50% improvement of the Clinical Activity Index (CAI) of the study.

  2 months

Study Arms (1)

Coltect

OTHER

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

Interventions

Coltect DIETARY_SUPPLEMENT

Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.

Coltect

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Gush-Dan, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Ulcer; Colitis; Inflammation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Iris Dotan, MD

CONTACT

+972-3-6947305; irisd@tasmc.health.gov.il

Nadir Arber, MD

CONTACT

+972-3-6974968; nadir@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 16, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 19, 2008

Record last verified: 2008-11

Locations

IL (1)