Evaulation of Interaction Between Herbal Products and Anticoagulants - Tabular View

Tracking Information

First Received Date ^ICMJE

October 29, 2003

Last Updated Date

October 1, 2007

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00071682 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaulation of Interaction Between Herbal Products and Anticoagulants

Official Title ^ICMJE

Early Identification of Adverse Reactions to Herbs

Brief Summary

The purpose of this study is to determine if the use of herbal products interferes with normal anticoagulation, leading to either excessive thinning of the blood and bleeding problems or inadequate thinning of the blood and clotting problems. Many patients who are on long term anticoagulation, or blood thinning, for a variety of medical problems, also take herbal products. It is not yet known whether use of herbal products interferes with this anticoagulation, and puts patients at risk for bleeding or clotting. This study will carefully monitor patients who are taking herbs and anticoagulants to determine if their laboratory tests show signs of being affected by the herbs. The study will ask all patients about their herbal product use, so all reported herbs will be included and monitored.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal, Defined Population, Prospective Study

Condition ^ICMJE

Coagulation Disorders

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

2000

Estimated Completion Date

March 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Taking longer-term (>6 months) anticoagulation
Enrolled in one of Kaiser Permanente Northern California anticoagulation clinics

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00071682

Responsible Party

Study ID Numbers ^ICMJE

K08 AT001338-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stephen Bent, MD

University of California, San Francisco

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP