Trial Outcomes & Findings for Ginger for Colorectal Cancer Prevention (NCT NCT01344538)
NCT ID: NCT01344538
Last Updated: 2016-08-11
Results Overview
% Change between baseline and day 28 in PGE2 levels standardized by protein
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline and day 28
Results posted on
2016-08-11
Participant Flow
Participant milestones
| Measure |
Ginger Root Extract
Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
|
Lactose Capsule
Placebo Capsule : 2.0 g per day
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ginger Root Extract
Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
|
Lactose Capsule
Placebo Capsule : 2.0 g per day
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Ginger for Colorectal Cancer Prevention
Baseline characteristics by cohort
| Measure |
Ginger Root Extract
n=16 Participants
Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
|
Lactose Capsule
n=17 Participants
Placebo Capsule : 2.0 g per day
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 28% Change between baseline and day 28 in PGE2 levels standardized by protein
Outcome measures
| Measure |
Lactose Capsule
n=16 Participants
Placebo Capsule : 2.0 g per day
|
Ginger Root Extract
n=14 Participants
Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
|
|---|---|---|
|
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.
|
31.9 percentage of change from baseline
Standard Deviation 89.8
|
-6.7 percentage of change from baseline
Standard Deviation 51.6
|
Adverse Events
Ginger Root Extract
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lactose Capsule
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ginger Root Extract
n=14 participants at risk
Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract)
|
Lactose Capsule
n=16 participants at risk
Placebo Capsule: 2.0 g per day
|
|---|---|---|
|
Gastrointestinal disorders
Stomach upset
|
35.7%
5/14
|
37.5%
6/16
|
|
General disorders
headache
|
7.1%
1/14
|
6.2%
1/16
|
|
General disorders
Fatigue
|
0.00%
0/14
|
6.2%
1/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place