UnknownPhase 2

Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis.

40 participantsStarted 2017-04

Plain-language summary

A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve treatment with 8 capsuls (2\*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or placebo for six months.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. An established clinical diagnosis of Familial Polyposis based on accepted clinical/ endoscopic and an identified APC or MUTYH mutation
✓. Age 18-70 years.
✓. Willing and able to give written consent.
✓. At least 5 polyps, 2mm or lrager, with at least one larger then 4mm but not more then 20mm.
✓. Colonic polyp burden that can be estimated by either counting or photographing(photo or video).

Exclusion criteria

✕. Pregnant or nursing women.
✕. Stable does of any COX inhibitor drugs for more than 3 months prior to study entry,.
✕. Concomitant severe or uncontrolled cardiovascular, hepatic, renal or metabolic disease.
✕. Known allergy to curcumin.
✕. Anticipated surgery within 6 months
✕. Diagnosed polyps of high grade dysplasia or of adenocarcinomas in the GI on screening colonoscopy.

What they're measuring

Number of polyps

Timeframe: 6 months

Size of polyps

Timeframe: 6 months

Trial details

NCT IDNCT03061591

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2018-04

Contact for this trial

Naomi Fliss, MSc

97236974458 naomifl@tlvmc.gov.il

View on ClinicalTrials.gov More Familial Adenomatous Polyposis trials