The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label
Recruitment status was Recruiting
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.
|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|
- 50% improvement of the Clinical Activity Index (CAI) of the study. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|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)|
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.
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|Contact: Iris Dotan, MDemail@example.com|
|Contact: Nadir Arber, MDfirstname.lastname@example.org|
|Tel-Aviv Sourasky Medical Center||Recruiting|
|Tel-Aviv, Gush-Dan, Israel, 64239|
|Contact: Iris Dotan, MD +972-3-6947305 email@example.com|
|Contact: Nadir Arber, MD +972-3-6974968 firstname.lastname@example.org|
|Principal Investigator: Iris Dotan, MD|
|Sub-Investigator: Nadir Arber, MD|
|Sub-Investigator: Aharon Hallak, MD|
|Sub-Investigator: Sigal Fishman, MD|