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Trial record 11 of 228 for:    yeast

Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

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ClinicalTrials.gov Identifier: NCT00639223
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Collaborator:
Chestnut Hill Health System
Information provided by:
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hypercholesterolemia
Statin-Associated Myopathy
Interventions Dietary Supplement: Red Yeast Rice
Drug: Pravastatin
Behavioral: Lifestyle modification program
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pravastatin Red Yeast Rice
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 22 21
Completed 22 19
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             2
Arm/Group Title Pravastatin Red Yeast Rice Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  63.6%
11
  52.4%
25
  58.1%
>=65 years
8
  36.4%
10
  47.6%
18
  41.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
62.9  (6.6) 62.4  (8.9) 62.7  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
16
  72.7%
16
  76.2%
32
  74.4%
Male
6
  27.3%
5
  23.8%
11
  25.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 43 participants
22 21 43
1.Primary Outcome
Title Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pravastatin Red Yeast Rice
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Participants
2 1
2.Secondary Outcome
Title Change in LDL-Cholesterol Measured at the Beginning and End of the Study
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pravastatin Red Yeast Rice
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: Percentage Change
-27.0  (15.4) -30.2  (10.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pravastatin Red Yeast Rice
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Pravastatin Red Yeast Rice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pravastatin Red Yeast Rice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pravastatin Red Yeast Rice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/22 (54.55%)      11/21 (52.38%)    
Gastrointestinal disorders     
Abdominal bloating or gas  0/22 (0.00%)  0 2/21 (9.52%)  2
Diarrhea  0/22 (0.00%)  0 2/21 (9.52%)  2
General disorders     
Fatigue  3/22 (13.64%)  3 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  6/22 (27.27%)  6 5/21 (23.81%)  5
Nervous system disorders     
Dizziness  2/22 (9.09%)  2 0/21 (0.00%)  0
Headache  2/22 (9.09%)  2 2/21 (9.52%)  2
Skin and subcutaneous tissue disorders     
Alopecia  0/22 (0.00%)  0 2/21 (9.52%)  2
Small sample size precluded definitive conclusions.
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: Steven Halbert MD, MSCE
Organization: U. of Pennsylvania Health System
Phone: 215 510 2221
EMail: shalbert@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: David Becker MD Principal Investigator, Chestnut Hill Health System
ClinicalTrials.gov Identifier: NCT00639223     History of Changes
Other Study ID Numbers: 806827
First Submitted: March 14, 2008
First Posted: March 20, 2008
Results First Submitted: December 9, 2009
Results First Posted: January 18, 2010
Last Update Posted: January 18, 2010