The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 50% improvement of the Clinical Activity Index (CAI) of the study. [ Time Frame: 2 months ]
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
|Contact: Iris Dotan, MDfirstname.lastname@example.org|
|Contact: Nadir Arber, MDemail@example.com|
|Tel-Aviv Sourasky Medical Center||Recruiting|
|Tel-Aviv, Gush-Dan, Israel, 64239|
|Contact: Iris Dotan, MD +972-3-6947305 firstname.lastname@example.org|
|Contact: Nadir Arber, MD +972-3-6974968 email@example.com|
|Principal Investigator: Iris Dotan, MD|
|Sub-Investigator: Nadir Arber, MD|
|Sub-Investigator: Aharon Hallak, MD|
|Sub-Investigator: Sigal Fishman, MD|