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Efficacy and Tolerability of Ginkgo Biloba Extract in Patients With Raynaud´s Phenomenon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.
ClinicalTrials.gov Identifier:
NCT00251238
First received: November 8, 2005
Last updated: May 16, 2017
Last verified: May 2017
Results First Received: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Raynaud Disease
Intervention: Drug: Ginkgo biloba extract EGb 761

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Group active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase
Placebo Group receiving matching placebo

Participant Flow:   Overall Study
    Intervention Group   Placebo Group
STARTED   21   20 
COMPLETED   21   20 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Group active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks
Control Group Receiving matching placebo
Total Total of all reporting groups

Baseline Measures
   Intervention Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   20   41 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20  95.2%      19  95.0%      39  95.1% 
>=65 years      1   4.8%      1   5.0%      2   4.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (13)   49  (13)   48  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  81.0%      18  90.0%      35  85.4% 
Male      4  19.0%      2  10.0%      6  14.6% 
Region of Enrollment 
[Units: Participants]
     
Netherlands   21   20   41 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Vasospastic Attacks   [ Time Frame: Number of Vasospastic Attacks per day, for up to 10 weeks ]

2.  Primary:   Duration of Vasospastic Attacks   [ Time Frame: minutes per day ]

3.  Primary:   Change From Baseline in Severity of Vasospastic Attacks   [ Time Frame: Baseline and 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. SJH Bredie, MD, PhD
Organization: Radboud University Nijmegen, The Netherlands
phone: 0031 24 3618819
e-mail: bas.bredie@radboudumc.nl



Responsible Party: Sebastian JH Bredie, MD, PhD, VSM Geneesmiddelen b.v.
ClinicalTrials.gov Identifier: NCT00251238     History of Changes
Other Study ID Numbers: 523052.01.002
Study First Received: November 8, 2005
Results First Received: January 12, 2015
Last Updated: May 16, 2017