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Trial record 37 of 45 for:    herbal medicine | United States

Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00103012
Recruitment Status : Completed
First Posted : February 7, 2005
Results First Posted : April 16, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy
Interventions: Drug: Gingko Biloba
Drug: Echinacea purpurea
Drug: Panax ginseng

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy human volunteers were recruited to participate in this study throughout the course of the investigation (2005-2010).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
Influence of Echinacea on Lopinavir/Ritonavir Disposition Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).

Participant Flow:   Overall Study
    Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition   Influence of Echinacea on Lopinavir/Ritonavir Disposition   Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
STARTED   17   14   16 
COMPLETED   14   13   12 
NOT COMPLETED   3   1   4 
Withdrawal by Subject                2                1                2 
Pregnancy                1                0                0 
Adverse Event                0                0                1 
Subject non-compliant with medications                0                0                1 



  Baseline Characteristics

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
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
Influence of Echinacea on Lopinavir/Ritonavir Disposition Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
Total Total of all reporting groups

Baseline Measures
   Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition   Influence of Echinacea on Lopinavir/Ritonavir Disposition   Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   14   16   47 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   17   14   16   47 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 33  (9.3)   33  (8.5)   32  (6.4)   33  (8.0) 
Gender 
[Units: Participants]
       
Female   9   5   4   18 
Male   8   9   12   29 
Region of Enrollment 
[Units: Participants]
       
United States   17   14   16   47 


  Outcome Measures

1.  Primary:   Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Scott Penzak
Organization: National Institutes of Health, Clinical Center, Department of Pharmacy
phone: 301-496-2997
e-mail: spenzak@cc.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00103012     History of Changes
Other Study ID Numbers: 050082
05-CC-0082
First Submitted: February 5, 2005
First Posted: February 7, 2005
Results First Submitted: December 12, 2011
Results First Posted: April 16, 2012
Last Update Posted: April 16, 2012