Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

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: NCT00718094
Recruitment Status : Completed
First Posted : July 18, 2008
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gerald W. Dryden, Jr., University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Mild to Moderately Active Ulcerative Colitis
Interventions Drug: Polyphenon E®
Drug: Placebo Oral Tablet
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polyphenon Treatment Placebo
Hide Arm/Group Description Polyphenon E®: Oral capsules for 56 days Placebo Oral Tablet: Oral tablet: placebo
Period Title: Overall Study
Started 15 5
Completed 15 5
Not Completed 0 0
Arm/Group Title Polyphenon E Treatment Placebo Total
Hide Arm/Group Description Polyphenon E®: Oral capsules

Oral Placebo

Placebo Oral Tablet: Oral tablet: placebo

Total of all reporting groups
Overall Number of Baseline Participants 15 5 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 5 participants 20 participants
44.9  (15) 30.7  (14.4) 40  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 5 participants 20 participants
Female
8
  53.3%
0
   0.0%
8
  40.0%
Male
7
  46.7%
5
 100.0%
12
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 5 participants 20 participants
15 5 20
Ulcerative colitis (UC) disease activity index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 5 participants 20 participants
6.5  (1.7) 7.3  (1.7) 7.0  (1.7)
[1]
Measure Description:

This is a standard method of measuring disease activity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity.

Each variable is scored from 0–3 so that the total index score ranges from 0–12; 0–2: remission; 3–6: mild; 7–10: moderate; >10: severe UC.

1.Primary Outcome
Title Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.
Hide Description

This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity.

Each variable is scored from 0–3 so that the total index score ranges from 0–12; 0–2: remission; 3–6: mild; 7–10: moderate; >10: severe UC.

Time Frame day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyphenon E Treatment Placebo
Hide Arm/Group Description:
Polyphenon E®: Oral capsules
Placebo Oral Tablet: Oral tablet: placebo
Overall Number of Participants Analyzed 15 5
Measure Type: Count of Participants
Unit of Measure: Participants
10
  66.7%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Polyphenon E Treatment, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyphenon E Treatment Placebo
Hide Arm/Group Description Polyphenon E®: Oral capsules Placebo Oral Tablet: Oral tablet: placebo
All-Cause Mortality
Polyphenon E Treatment Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Polyphenon E Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/5 (0.00%)    
Gastrointestinal disorders     
Hospitalization   1/15 (6.67%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Polyphenon E Treatment Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/5 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerald Dryden, MD
Organization: University Louisville
Phone: 502-852-0156
EMail: gwdryd01@louisville.edu
Layout table for additonal information
Responsible Party: Gerald W. Dryden, Jr., University of Louisville
ClinicalTrials.gov Identifier: NCT00718094     History of Changes
Other Study ID Numbers: 390.05
5K23DK073750 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2008
First Posted: July 18, 2008
Results First Submitted: April 12, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017