Oral PainNCT00200837
Ethnopharmacological Studies in Oral Medicine
An observational study of Oral Pain and Oral Ulcers, run by National Center for Complementary and Integrative Health (NCCIH) at 3 sites in 3 countries.
Trial summary
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Pain, Oral Ulcers, Oral Tumors
- How many people
- 1,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2002to Feb 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who use plants to relieve oral pain, inflammations, ulcers, and tumors
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.
Read the detailed description
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain relief in Central and South America.
- Conditions
- Oral Pain, Oral Ulcers, Oral Tumors
- Keywords
- oral mucosal pain, oral inflammations, anisillo, cordonsillo, Piperaceae, oral ulcers, oral tumors, mucosal pain, mucosal inflammations, cordoncillo
- Medical subject headings
- Oral Ulcer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2002
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral PainStudies 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
- Natural history
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Illinois Chicago, Latin University of Costa Rica
- Investigators
- Michael D Colvard, DDS, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200837
- Sponsor's protocol ID
- K08AT000987-01
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 28 Mar 2007
- Results posted
- No
Publications
Colvard MD, Ashrafi SH, Alonge OK, Cordell GA. Smokeless tobacco-induced lamellar body abnormalities. Oral Dis. 2006 May;12(3):343-8. doi: 10.1111/j.1601-0825.2005.01211.x.
PubMed 16700746Alonge OK, Ashrafi SH, Colvard MD. Mitochondrial volume densities in the smokeless tobacco-treated hamster cheek pouch epithelium. Oral Dis. 2003 May;9(3):138-43. doi: 10.1034/j.1601-0825.2003.01814.x.
PubMed 12945595Colvard MD, Cordell GA, Villalobos R, Sancho G, Soejarto DD, Pestle W, Echeverri TL, Perkowitz KM, Michel J. Survey of medical ethnobotanicals for dental and oral medicine conditions and pathologies. J Ethnopharmacol. 2006 Aug 11;107(1):134-42. doi: 10.1016/j.jep.2006.04.005. Epub 2006 Apr 18.
PubMed 16735102Cordell GA, Colvard MD. Some thoughts on the future of ethnopharmacology. J Ethnopharmacol. 2005 Aug 22;100(1-2):5-14. doi: 10.1016/j.jep.2005.05.027.
PubMed 16009517
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnopharmacological Studies in Oral Medicine
- ClinicalTrials.gov ID
- NCT00200837
- Acronym / sponsor ID
- K08AT000987-01
- Conditions
- Oral Pain, Oral Ulcers, Oral Tumors
- Keywords
- oral mucosal pain, oral inflammations, anisillo, cordonsillo, Piperaceae, oral ulcers, oral tumors, mucosal pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- University of Illinois Chicago, Latin University of Costa Rica
- Study start
- Mar 2002
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Sep 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.
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.
Detailed description
These are ethnomedicine studies of plants used by rural and indigenous peoples for pain relief in Central and South America.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who use plants to relieve oral pain, inflammations, ulcers, and tumors
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
Not reported in the source record.
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 28 Mar 2007.
- Background: PubMed 16700746Colvard MD, Ashrafi SH, Alonge OK, Cordell GA. Smokeless tobacco-induced lamellar body abnormalities. Oral Dis. 2006 May;12(3):343-8. doi: 10.1111/j.1601-0825.2005.01211.x.
- Background: PubMed 12945595Alonge OK, Ashrafi SH, Colvard MD. Mitochondrial volume densities in the smokeless tobacco-treated hamster cheek pouch epithelium. Oral Dis. 2003 May;9(3):138-43. doi: 10.1034/j.1601-0825.2003.01814.x.
- Background: PubMed 16735102Colvard MD, Cordell GA, Villalobos R, Sancho G, Soejarto DD, Pestle W, Echeverri TL, Perkowitz KM, Michel J. Survey of medical ethnobotanicals for dental and oral medicine conditions and pathologies. J Ethnopharmacol. 2006 Aug 11;107(1):134-42. doi: 10.1016/j.jep.2006.04.005. Epub 2006 Apr 18.
- Background: PubMed 16009517Cordell GA, Colvard MD. Some thoughts on the future of ethnopharmacology. J Ethnopharmacol. 2005 Aug 22;100(1-2):5-14. doi: 10.1016/j.jep.2005.05.027.
- Mitochondrial volume densities in the smokeless tobacco-treated hamster cheek pouch epithelium.Link provided by the sponsor.
- Smokeless tobacco-induced lamellar body abnormalities.Link provided by the sponsor.
- Survey of medical ethnobotanicals for dental and oral medicine conditions and pathologies.Link provided by the sponsor.
- Some thoughts on the Future of EthnopharmacologyLink provided by the sponsor.
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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 D Colvard, DDS principal investigator
University of Illinois Chicago
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Pain and Oral Ulcers, run by National Center for Complementary and Integrative Health (NCCIH) at 3 sites in 3 countries.
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 1 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 28 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Colombia, Costa Rica. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00200837, which also lists 4 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 28 Mar 2007.