InflammationNCT00109980
Medicinal Plant Use for Treating Inflammation Among Dominicans in New York City and the Dominican Republic
An observational study of Inflammation, run by New York Botanical Garden at 1 site in United States.
Trial summary
The purpose of this study is to investigate and compare the use of herbal medicine among Dominicans in New York City and the Dominican Republic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dominican community sample in New York City
Who may be able to join
- Dominican ethnicity
- Have knowledge of Dominican medicinal plants
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Associates in Internal Medicine Clinic, New York-Presbyterian Hospital, Columbia University
New York, New York, 10032
About this study
Official title: Dominican Herbal Medicine: Plants Used for Inflammation
The purpose of this study is to investigate and compare the use of herbal medicine among Dominicans in New York City and the Dominican Republic.
Read the detailed description
According to the 2000 U.S. Census Report, Dominicans constitute the largest Hispanic immigrant group in New York City. Studies have shown that immigrants' use of traditional and herbal medicine is close to that of native-born Americans. However, minority immigrants often have limited access to traditional health care; as a result, they may be more likely to consult with traditional healers and use medicinal plants than nonimmigrants. This study is designed to increase knowledge about immigrants' health and to contribute to more culturally-sensitive health care. The purpose of this study is to determine medical plant knowledge and use among Dominican traditional healers and patients in New York City and in the Dominican Republic.
This study will comprise two parts. In Part I, Dominican medicinal plant users and Dominican traditional healers in New York City will be questioned about the medicinal plant species they know and how they are used for prevalent illnesses. The same number of participants will be interviewed in the Dominican Republic, allowing for detailed comparisons between the two study sites.
In Part II, the most frequently-cited medicinal plant species will be subjected to a thorough literature review on their pharmacologic activity and the chemical composition of their active constituents. Two in vitro assays will be used to measure the anti-inflammatory activity of certain plant extracts, and their anti-inflammatory compounds will be isolated and characterized for the purpose of standardization of active extracts. On the basis of these results, recommendations will be formulated for future studies and community use of selected medicinal plant species.
- Conditions
- Inflammation
- Keywords
- Complementary Therapies, Plants, Medicinal, Dominican Republic, Hispanic Americans
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of culturally important medicinal plants
Measured: June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Botanical Garden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Balick, National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Michael J. Balick, PhD, Principal investigator, Institute of Economic Botany, the New York Botanical Garden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109980
- Sponsor's protocol ID
- R21AT001889-01A1
- Status last verified
- Oct 2013
- First submitted
- 3 May 2005
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Balick MJ, Kronenberg F, Ososki AL, Reiff M, Fugh-Berman A, O'Connor B, Roble M, Lohr P, Atha D. Medicinal plants used by Latino healers for women's health conditions in New York City. Economic Botany 54: 344-357, 2000.
Balick MJ, Lee R. Looking within: urban ethnomedicine and ethnobotany. Altern Ther Health Med. 2001 Jul-Aug;7(4):114-5. No abstract available.
PubMed 11452554Fugh-Berman A, Balick MJ, Kronenberg F, Ososki AL, O'Connor B, Reiff M, Roble M, Lohr P, Brosi BJ, Lee R. Treatment of fibroids: the use of beets (Beta vulgaris) and molasses (Saccharum officinarum) as an herbal therapy by Dominican healers in New York City. J Ethnopharmacol. 2004 Jun;92(2-3):337-9. doi: 10.1016/j.jep.2004.03.009. No abstract available.
PubMed 15138021Ososki AL, Lohr P, Reiff M, Balick MJ, Kronenberg F, Fugh-Berman A, O'Connor B. Ethnobotanical literature survey of medicinal plants in the Dominican Republic used for women's health conditions. J Ethnopharmacol. 2002 Mar;79(3):285-98. doi: 10.1016/s0378-8741(01)00376-2.
PubMed 11849831Reiff M, O'Connor B, Kronenberg F, Balick M, Lohr P, Roble M, Fugh-Berman A, Johnson KD. Ethnomedicine in the urban environment: Dominican healers in New york City. Human Organization 62(1): 12-26, 2003.
Vandebroek I, Balick MJ, Yukes J, Duran L, Kronenberg F, Wade C, Ososki AL, Cushman L, Lantigua R, Mejia M & Robineau L (2007) Use of medicinal plants by Dominican immigrants in New York City for the treatment of common health conditions. A comparative analysis with literature data from the Dominican Republic. In: A. Pieroni & I. Vandebroek, eds., Traveling Cultures and Plants: The Ethnobiology and Ethnopharmacy of Human Migrations. Bergahn Books, New York, pp. 39-63.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dominican Herbal Medicine: Plants Used for Inflammation
- ClinicalTrials.gov ID
- NCT00109980
- Acronym / sponsor ID
- R21AT001889-01A1
- Conditions
- Inflammation
- Keywords
- Complementary Therapies, Plants, Medicinal, Dominican Republic, Hispanic Americans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- New York Botanical GardenUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jul 2011 (actual)
- First posted
- 4 May 2005 (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.
The purpose of this study is to investigate and compare the use of herbal medicine among Dominicans in New York City and the Dominican Republic.
Detailed description
According to the 2000 U.S. Census Report, Dominicans constitute the largest Hispanic immigrant group in New York City. Studies have shown that immigrants' use of traditional and herbal medicine is close to that of native-born Americans. However, minority immigrants often have limited access to traditional health care; as a result, they may be more likely to consult with traditional healers and use medicinal plants than nonimmigrants. This study is designed to increase knowledge about immigrants' health and to contribute to more culturally-sensitive health care. The purpose of this study is to determine medical plant knowledge and use among Dominican traditional healers and patients in New York City and in the Dominican Republic.
This study will comprise two parts. In Part I, Dominican medicinal plant users and Dominican traditional healers in New York City will be questioned about the medicinal plant species they know and how they are used for prevalent illnesses. The same number of participants will be interviewed in the Dominican Republic, allowing for detailed comparisons between the two study sites.
In Part II, the most frequently-cited medicinal plant species will be subjected to a thorough literature review on their pharmacologic activity and the chemical composition of their active constituents. Two in vitro assays will be used to measure the anti-inflammatory activity of certain plant extracts, and their anti-inflammatory compounds will be isolated and characterized for the purpose of standardization of active extracts. On the basis of these results, recommendations will be formulated for future studies and community use of selected medicinal plant species.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dominican community sample in New York City
Key inclusion criteria (2 listed)
- Dominican ethnicity
- Have knowledge of Dominican medicinal plants
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of culturally important medicinal plants
Time frame: June 2010
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 1 Nov 2013.
- BackgroundBalick MJ, Kronenberg F, Ososki AL, Reiff M, Fugh-Berman A, O'Connor B, Roble M, Lohr P, Atha D. Medicinal plants used by Latino healers for women's health conditions in New York City. Economic Botany 54: 344-357, 2000.
- Background: PubMed 11452554Balick MJ, Lee R. Looking within: urban ethnomedicine and ethnobotany. Altern Ther Health Med. 2001 Jul-Aug;7(4):114-5. No abstract available.
- Background: PubMed 15138021Fugh-Berman A, Balick MJ, Kronenberg F, Ososki AL, O'Connor B, Reiff M, Roble M, Lohr P, Brosi BJ, Lee R. Treatment of fibroids: the use of beets (Beta vulgaris) and molasses (Saccharum officinarum) as an herbal therapy by Dominican healers in New York City. J Ethnopharmacol. 2004 Jun;92(2-3):337-9. doi: 10.1016/j.jep.2004.03.009. No abstract available.
- Background: PubMed 11849831Ososki AL, Lohr P, Reiff M, Balick MJ, Kronenberg F, Fugh-Berman A, O'Connor B. Ethnobotanical literature survey of medicinal plants in the Dominican Republic used for women's health conditions. J Ethnopharmacol. 2002 Mar;79(3):285-98. doi: 10.1016/s0378-8741(01)00376-2.
- BackgroundReiff M, O'Connor B, Kronenberg F, Balick M, Lohr P, Roble M, Fugh-Berman A, Johnson KD. Ethnomedicine in the urban environment: Dominican healers in New york City. Human Organization 62(1): 12-26, 2003.
- BackgroundVandebroek I, Balick MJ, Yukes J, Duran L, Kronenberg F, Wade C, Ososki AL, Cushman L, Lantigua R, Mejia M & Robineau L (2007) Use of medicinal plants by Dominican immigrants in New York City for the treatment of common health conditions. A comparative analysis with literature data from the Dominican Republic. In: A. Pieroni & I. Vandebroek, eds., Traveling Cultures and Plants: The Ethnobiology and Ethnopharmacy of Human Migrations. Bergahn Books, New York, pp. 39-63.
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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.
Michael J. Balick, PhD principal investigator
Institute of Economic Botany, the New York Botanical Garden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation, run by New York Botanical Garden at 1 site in United States.
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 0 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Identification of culturally important medicinal plants (time frame: June 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00109980, which also lists 6 linked publications.
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 1 Nov 2013.