Ginger for Colorectal Cancer Prevention

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Placebo Capsule; Drug: Ginger Root Extract (Pure Encapsulations)

• Registration Number: NCT01344538
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to determine if ginger root extract when taken daily for 28 days is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of people who are at normal risk and those at increased of developing colorectal cancer compared to people taking placebo.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2011-05
• Study Completion: 2012-12
• Results First Submitted: 2014-06-16
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-30
• Last Update Submitted: 2016-06-30
• Results First Posted: 2016-08-11
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactose Capsule	Placebo Capsule	-
Ginger Root Extract	Ginger Root Extract (Pure Encapsulations)	-

Primary Outcome Measures

Name	Time	Method
Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo.	Baseline and day 28	% Change between baseline and day 28 in PGE2 levels standardized by protein

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States