Herb-drug InteractionsNCT00564473
Use of Herbal Medicine in Internal Medicine Wards
An observational study of Herb-drug Interactions, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herb-drug Interactions
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2008to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in a department of internal medicine
Who may be able to join
- Patients of either gender
- Age 18 years and older
Who cannot join
- Neurological deficit or other medical condition precluding responding to the questionnaires.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 91031
Shaare Zedek Medical Center
Jerusalem
About this study
Official title: Use of Herbal Medicine Among Patients Hospitalized in a Department of Internal Medicine: A Cross-Sectional Survey
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.
- Conditions
- Herb-drug Interactions
- Being tested
- questionnaire
- Keywords
- internal medicine, herbal medicine, prevalence, attitudes, herb-drug interaction
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
- questionnaire of demographic and medical data, use of and attituded toward herbal medicine.
- Beck Depression Inventory-Second Edition (BDI-II)- Hebrew Translation
| Study group | Role | What they receive |
|---|---|---|
| A | patients hospitalized in the Department of Internal Medicine of the Shaare Zedek Medical Center, Jerusalem, Israel. Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
* prevalence of use of herbal medicine among patients hospitalized in the Department of Internal Medicine at the Shaare Zedek Medical Center in Jerusalem, Israel.
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startJun 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herb-drug InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Noah Samuels, MD, Principal investigator, Shaare Zedek Medical CenterShoshanna Zevin, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564473
- Sponsor's protocol ID
- HERB.INTMED.08
- Status last verified
- Oct 2010
- First submitted
- 27 Nov 2007
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Herbal Medicine Among Patients Hospitalized in a Department of Internal Medicine: A Cross-Sectional Survey
- ClinicalTrials.gov ID
- NCT00564473
- Acronym / sponsor ID
- HERB.INTMED.08
- Conditions
- Herb-drug Interactions
- Keywords
- internal medicine, herbal medicine, prevalence, attitudes, herb-drug interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: questionnairepatients hospitalized in the Department of Internal Medicine of the Shaare Zedek Medical Center, Jerusalem, Israel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in a department of internal medicine
Key inclusion criteria (2 listed)
- Patients of either gender
- Age 18 years and older
Key exclusion criteria (1 listed)
- Neurological deficit or other medical condition precluding responding to the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire* questionnaire of demographic and medical data, use of and attituded toward herbal medicine. * Beck Depression Inventory-Second Edition (BDI-II)- Hebrew Translation | Behavioural | A |
Primary outcome
* 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
1 secondary outcome
*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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
Related trials for Herb-drug Interactions
RecruitingObservational study
Developing a Methodological Framework and a Dissemination Plan for Herb-drug Interactions-related Clinical Practice Guidelines
Herb-drug Interactions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Samuels, MD principal investigator
Shaare Zedek Medical Center
Shoshanna Zevin, MD principal investigator
Shaare Zedek Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herb-drug Interactions, run by Shaare Zedek Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
* 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010.