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Ginger for Colorectal Cancer Prevention

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: NCT01344538
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Suzanna Zick, University of Michigan

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE April 29, 2011
Results First Submitted Date  ICMJE June 16, 2014
Results First Posted Date  ICMJE August 11, 2016
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE April 2007
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
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. [ Time Frame: Baseline and day 28 ]
% Change between baseline and day 28 in PGE2 levels standardized by protein
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
Determine changes in levels from baseline of prostaglandin E2 [ Time Frame: Baseline and day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ginger for Colorectal Cancer Prevention
Official Title  ICMJE Phase II Study of the Effects of Ginger Root Extract on Eicosanoids in Colon Mucosa in People at Normal Risk for Colorectal Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Ginger Root Extract (Pure Encapsulations)
    2.0 g per day (10:1 extract)
  • Dietary Supplement: Placebo Capsule
    2.0 g per day
Study Arms  ICMJE
  • Experimental: Ginger Root Extract
    Intervention: Drug: Ginger Root Extract (Pure Encapsulations)
  • Placebo Comparator: Lactose Capsule
    Intervention: Dietary Supplement: Placebo Capsule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2011)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria Normal Risk:

  • 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
  • No chronic medication use was allowed and participants could not have taken aspirin or related NSAIDs during the study or 14 days before the first dose of the study medication.
  • Participants also had to be classified as being at normal-risk for developing colorectal cancer. Normal-risk was defined as having: no first-degree relatives with colon cancer diagnosed before the age of 60; no personal history of colorectal cancer and no adenomas >1 cm in size or containing carcinoma in situ

Exclusion Criteria for both Normal and Increased Risk for Colorectal Cancer:

  1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors;
  2. pregnant or lactating women;
  3. history of cardiovascular disease;
  4. lactose intolerance;
  5. or an allergy to ginger
  6. a history of familial colorectal cancer syndromes;.

Inclusion Criteria Increased Risk:

  • 18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
  • No chronic medication use was allowed and participants could not have taken aspirin or related NSAIDs during the study or 14 days before the first dose of the study medication.
  • Participants also had to be classified as being at increased-risk for developing colorectal cancer. Increased-risk is defined as having at least one of the following: a first-degree relatives with colon cancer diagnosed before the age of 60; a personal history of early stage colorectal cancer and/or no adenomas >1 cm in size or containing carcinoma in situ
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01344538
Other Study ID Numbers  ICMJE Ginger-01HR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzanna Zick, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
PRS Account University of Michigan
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP