NCT00564473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

1.7 years

First QC Date

November 27, 2007

Last Update Submit

October 28, 2010

Conditions

Keywords

internal medicineherbal medicineprevalenceattitudesherb-drug interaction

Outcome Measures

Primary Outcomes (1)

  • * prevalence of use of herbal medicine among patients hospitalized in the Department of Internal Medicine at the Shaare Zedek Medical Center in Jerusalem, Israel.

    one year

Secondary Outcomes (1)

  • *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

    one year

Study Arms (1)

A

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

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

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

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients hospitalized in a department of internal medicine

You may qualify if:

  • Patients of either gender
  • Age 18 years and older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Behavior

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Noah Samuels, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR
  • Shoshanna Zevin, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

June 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations