The Effect of Coltect (Selenium, Curcumin and Green Tea) on Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT01167673|
Recruitment Status : Unknown
Verified June 2016 by NAFTALI TIMNA, Meir Medical Center.
Recruitment status was: Recruiting
First Posted : July 22, 2010
Last Update Posted : June 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Dietary Supplement: coltect Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double Blind Placebo Controlled Cross Over Study for the Use of Coltect (Green Tea, Selenium and Curcumin) in Irritable Bowel Syndrome|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Active Comparator: treatment with study drug
patients receiving study drug for 4 weeks. 3 capsules a day of coltect
Dietary Supplement: coltect
green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
Placebo Comparator: placebo
patients receiving similar capsules but no active ingredients
Dietary Supplement: Placebo
- improvement of IBS symptoms and quality of life [ Time Frame: 10 weeks ]improvement of IBS symptoms and quality of life (QOL) assessed by IBS and QOL questionaires.
- change in bacterial stool flora [ Time Frame: 10 weeks ]stool tests to investigate change in intestinal flora during the study.
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): NCT01167673
|Contact: AYA Oren, MDemail@example.com|
|Principal Investigator:||Timna Naftali, MD||Meir MC|