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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
Enrollment 47
Recruitment Details Healthy human volunteers were recruited to participate in this study throughout the course of the investigation (2005-2010).
Pre-assignment Details  
Arm/Group Title Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Influence of Echinacea on Lopinavir/Ritonavir Disposition Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Hide Arm/Group Description 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. 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). 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).
Period Title: Overall Study
Started 17 14 16
Completed 14 13 12
Not Completed 3 1 4
Reason Not Completed
Withdrawal by Subject             2             1             2
Pregnancy             1             0             0
Adverse Event             0             0             1
Subject non-compliant with medications             0             0             1
Arm/Group Title Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Influence of Echinacea on Lopinavir/Ritonavir Disposition Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition Total
Hide Arm/Group Description 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. 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). 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 of all reporting groups
Overall Number of Baseline Participants 17 14 16 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 16 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
14
 100.0%
16
 100.0%
47
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 16 participants 47 participants
33  (9.3) 33  (8.5) 32  (6.4) 33  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 16 participants 47 participants
Female
9
  52.9%
5
  35.7%
4
  25.0%
18
  38.3%
Male
8
  47.1%
9
  64.3%
12
  75.0%
29
  61.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 14 participants 16 participants 47 participants
17 14 16 47
1.Primary Outcome
Title Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.
Hide Description The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was analyzed from all subjects who completed a particular sampling period.
Arm/Group Title Influence of Ginkgo Biloba on Lopinavir Disposition Influence of Echinacea on Lopinavir Disposition Influence of Panax Ginseng on Lopinavir Disposition
Hide Arm/Group Description:
Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
Overall Number of Participants Analyzed 14 13 12
Geometric Mean (90% Confidence Interval)
Unit of Measure: mcg*hr/mL
1.02
(0.67 to 1.38)
0.96
(0.83 to 1.10)
1
(0.3 to 2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Influence of Echinacea on Lopinavir/Ritonavir Disposition Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Hide Arm/Group Description 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. 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). 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).
All-Cause Mortality
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Influence of Echinacea on Lopinavir/Ritonavir Disposition Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Influence of Echinacea on Lopinavir/Ritonavir Disposition Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/14 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition Influence of Echinacea on Lopinavir/Ritonavir Disposition Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      13/14 (92.86%)      15/16 (93.75%)    
Blood and lymphatic system disorders       
decreased serum albumin  0/17 (0.00%)  0 0/14 (0.00%)  0 3/16 (18.75%)  3
decreased hemoglobin  0/17 (0.00%)  0 0/14 (0.00%)  0 2/16 (12.50%)  2
Cardiac disorders       
bradycardia  0/17 (0.00%)  0 0/14 (0.00%)  0 2/16 (12.50%)  2
Eye disorders       
conjunctivitis  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Gastrointestinal disorders       
diarrhea  1/17 (5.88%)  2 11/14 (78.57%)  26 9/16 (56.25%)  22
nausea  0/17 (0.00%)  0 5/14 (35.71%)  5 3/16 (18.75%)  3
abdominal pain  0/17 (0.00%)  0 5/14 (35.71%)  7 2/16 (12.50%)  5
flatulence  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
vomiting  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
dry mouth  0/17 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  2
General disorders       
taste alterations  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
cough  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
generalized pain  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
common cold  1/17 (5.88%)  2 0/14 (0.00%)  0 1/16 (6.25%)  1
fatigue  0/17 (0.00%)  0 0/14 (0.00%)  0 2/16 (12.50%)  3
Hepatobiliary disorders       
elevated ALT (SGPT)  0/17 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
elevated AST (SGOT)  0/17 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
elevated serum bilirubin  0/17 (0.00%)  0 0/14 (0.00%)  0 3/16 (18.75%)  3
Immune system disorders       
decreased absolute neutrophil count  0/17 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations       
acute sore throat  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
sinus congestion  0/17 (0.00%)  0 1/14 (7.14%)  2 0/16 (0.00%)  0
fever  0/17 (0.00%)  0 1/14 (7.14%)  1 1/16 (6.25%)  2
Injury, poisoning and procedural complications       
anorexia  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders       
electrolyte imbalance  1/17 (5.88%)  2 0/14 (0.00%)  0 0/16 (0.00%)  0
hypertriglyceridemia  0/17 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
hypercholesterolemia  0/17 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders       
myalgia  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Nervous system disorders       
headache  0/17 (0.00%)  0 2/14 (14.29%)  2 7/16 (43.75%)  10
insomnia  0/17 (0.00%)  0 1/14 (7.14%)  1 1/16 (6.25%)  1
decreased concentration  0/17 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Reproductive system and breast disorders       
dysmenorrhea  1/17 (5.88%)  2 0/14 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders       
rash  0/17 (0.00%)  0 0/14 (0.00%)  0 3/16 (18.75%)  3
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
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