Use of Herbal Medicine in Internal Medicine Wards

• ClinicalTrials.gov Identifier: NCT00564473
• Recruitment Status: Completed
• First Posted: November 28, 2007
• Last Update Posted: October 29, 2010
• Sponsor: Shaare Zedek Medical Center
• Information provided by: Shaare Zedek Medical Center

Tracking Information

• First Submitted Date: November 27, 2007
• First Posted Date: November 28, 2007
• Last Update Posted Date: October 29, 2010
• Study Start Date: June 2008
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 27, 2007): * prevalence of use of herbal medicine among patients hospitalized in the Department of Internal Medicine at the Shaare Zedek Medical Center in Jerusalem, Israel. [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 27, 2007): *prevalence of herb-drug interactions affecting treatment *rates of reporting use of herbal remedies *prevalence of toxic effects of herbal remedies *attitudes toward herbal medicine [ Time Frame: one year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Herbal Medicine in Internal Medicine Wards
• Official Title: Use of Herbal Medicine Among Patients Hospitalized in a Department of Internal Medicine: A Cross-Sectional Survey
• Brief Summary: Herbs are physiologically active substances which can significantly affect the outcome of medical treatment, either by inhibiting or promoting drug disposition or through additive and synergistic effects when used in conjunction with conventional medications. Herb-drug interactions are potentially dangerous, and may be difficult to predict since regulation of the preparations is often lacking, and patients most often do not report the use of these products to their physicians. The risk for toxic effects and adverse interactions increases among high-risk groups, such as the elderly or patients with renal or hepatic disease. The purpose of this study is to study the prevalence of use of herbal medicine among patients hospitalized in the internal medicine department of an Israeli hospital, as well as examine the effect of herbal remedies on patient health, either beneficial or harmful. For this purpose, a questionnaire evaluating demographic data, medical history (both current and past), use of and attitudes towards herbal medicine will be administered to patients in the Department of Internal Medicine at the Shaare Zedek Medical Center in Israel. The Beck Depression Questionnaire will be used as well.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients hospitalized in a department of internal medicine
• Condition: Herb-drug Interactions

Intervention

Behavioral: questionnaire

• questionnaire of demographic and medical data, use of and attituded toward herbal medicine.
• Beck Depression Inventory-Second Edition (BDI-II)- Hebrew Translation

Study Groups/Cohorts

A

patients hospitalized in the Department of Internal Medicine of the Shaare Zedek Medical Center, Jerusalem, Israel.

Intervention: Behavioral: questionnaire

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 27, 2007): 200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients of either gender
• Age 18 years and older

Exclusion Criteria:

• Neurological deficit or other medical condition precluding responding to the questionnaires.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00564473
• Other Study ID Numbers: HERB.INTMED.08
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center
• Study Sponsor: Shaare Zedek Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Noah Samuels, MD; Shaare Zedek Medical Center
• Principal Investigator: Shoshanna Zevin, MD; Shaare Zedek Medical Center

• PRS Account: Shaare Zedek Medical Center
• Verification Date: October 2010