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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Colorectal Cancer
Interventions Drug: Ginger Root Extract (Pure Encapsulations)
Dietary Supplement: Placebo Capsule
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ginger Root Extract Lactose Capsule
Hide Arm/Group Description Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract) Placebo Capsule : 2.0 g per day
Period Title: Overall Study
Started 16 17
Completed 14 16
Not Completed 2 1
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             1             0
Arm/Group Title Ginger Root Extract Lactose Capsule Total
Hide Arm/Group Description Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract) Placebo Capsule : 2.0 g per day Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
33 people enrolled with 3 withdrawn
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
34.5  (13.1) 33.4  (10.1) 34.0  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
9
  56.3%
8
  47.1%
17
  51.5%
Male
7
  43.8%
9
  52.9%
16
  48.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 17 participants 33 participants
16 17 33
1.Primary Outcome
Title 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.
Hide Description % Change between baseline and day 28 in PGE2 levels standardized by protein
Time Frame Baseline and day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactose Capsule Ginger Root Extract
Hide Arm/Group Description:
Placebo Capsule : 2.0 g per day
Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
31.9  (89.8) -6.7  (51.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lactose Capsule, Ginger Root Extract
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ginger Root Extract Lactose Capsule
Hide Arm/Group Description Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract) Placebo Capsule: 2.0 g per day
All-Cause Mortality
Ginger Root Extract Lactose Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ginger Root Extract Lactose Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ginger Root Extract Lactose Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   5/14 (35.71%)   7/16 (43.75%) 
Gastrointestinal disorders     
Stomach upset   5/14 (35.71%)  6/16 (37.50%) 
General disorders     
headache   1/14 (7.14%)  1/16 (6.25%) 
Fatigue   0/14 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Suzanna M Zick
Organization: University of Michigan
Phone: 734-998-9553
EMail: szick@umich.edu
Layout table for additonal information
Responsible Party: Suzanna Zick, University of Michigan
ClinicalTrials.gov Identifier: NCT01344538    
Other Study ID Numbers: Ginger-01HR
First Submitted: April 27, 2011
First Posted: April 29, 2011
Results First Submitted: June 16, 2014
Results First Posted: August 11, 2016
Last Update Posted: August 11, 2016