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Screening Herbs for Drug Interactions Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Screening Herbs for Drug Interactions conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Screening Herbs for Drug Interactions Clinical research trials and Screening Herbs for Drug Interactions health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Screening Herbs for Drug Interactions. Screening Herbs for Drug Interactions Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Screening Herbs for Drug Interactions clinical trial. Human subjects often get the best healthcare possible for their Screening Herbs for Drug Interactions condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Screening Herbs for Drug Interactions  Screening Herbs for Drug Interactions
Screening Herbs for Drug Interactions
For Condition: Healthy
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The present study is designed to detect potential herb-drug interactions in human volunteers. Research subjects, who have had physicals and found to be healthy, and, who are taking no medications or supplements, will receive a single dose of the prescription drug alprazolam and the over-the-counter cough suppressant, dextromethorphan on two occasions. Once by themselves, and again after taking a selected herbal product for 2 weeks. Comparisons will be made between the blood and urine levels of alprazolam and dextromethorphan, respectively, between the two treatment phases. This information will allow us to make predictions on potential herb-drug interactions with many prescription medications.
Details: The use of herbal agents by the lay public and medical professionals has accelerated in the last decade. Additionally, there has been increasing interest by the NIH National Center for Complementary & Alternative Medicine (NCCAM) and others in the safety and efficacy of herbal medicines in the treatment of a variety of medical and psychiatric conditions. It has also become evident that herbal medications are being used concomitantly with conventional prescription and over-the-counter medications. However, the systematic evaluation of the potential of these agents to interact with conventional medications has been generally neglected. Compounding this problem is the fact that even single entity herbal products can contain a multitude of naturally occurring chemicals which serve as candidates for potential herb-drug interactions by inhibiting or inducing specific hepatic isozymes. Numerous reports document the importance of pharmacokinetic interactions involving inhibition or induction of the cytochrome P450 (CYP) enzyme system. Importantly, recent publications have documented that clinically significant herb-drug interactions can occur. Prominent examples include herb-induced reductions in plasma concentrations of the anti-HIV medication indinavir and the immunosuppressant cyclosporine by St. John's wort (Hypericum perforatum). In vitro screening studies are of limited value due to difficulties in approximating physiologic concentrations, assessing the influence of non-hepatic metabolism, and accounting for the contribution of active metabolites. However, based upon findings of the effects of concurrently administered herbs on the metabolism of enzyme specific probe drug substrates alprazolam (CYP 3A4) and dextromethorphan (CYP 2D6), the potential specificity and magnitude of CYP enzyme inhibition and/or induction can be determined in normal volunteers. In a preliminary study in human subjects using this validated probe drug technique assessing inhibitory effects only, the investigators found no effects of St. John's wort on CYP 3A4 or CYP 2D6. In the present proposal, the 10 most commonly used herbal products in the US will be systematically evaluated for inhibition of CYP 3A4 and 2136, and induction of CYP 3A4. Collectively, these enzyme systems are involved in the metabolism of approximately 80% of all marketed medications. A combination of probe drugs will be given to normal volunteers both in the absence and presence of herbal medications. The plasma and urine concentration of these agents and their respective metabolites will be determined in order to evaluate individual herbal products degree and specificity of enzyme inhibitory or inductive effects. This data will fill a void regarding the relative safety of combining specific herbal agents with conventional medications and will serve as the basis for further investigations of other isozymes and herb interactions. Further, the proposed studies will complement existing and future NCCAM studies of agents such as St. John's wort and Gingko biloba.
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Normal healthy volunteers who are taking no medications. - Must be non-smokers.
Total Enrollment: 140
Location and Contact Information:
Institute of Psychiatry, Medical University of SC *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting John Markowitz 843-792-0172
Additional Information:
Study ID Numbers: 1 R21 AT00511-01;
Study Start Date: August 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029263
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Screening Herbs for Drug Interactions
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