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NCT00525421 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus
A Phase 2 study of Oral Lichen Planus, sponsored by Nita Chainani Wu.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00525421: Completed Phase 2 study of Oral Lichen Planus, sponsored by Nita Chainani Wu.
NCT00525421 is a Phase 2 study of Oral Lichen Planus that has completed, run by Nita Chainani Wu. The registered enrollment target is 20 participants, roughly in line with the 19-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00525421, a Phase 2 study of Oral Lichen Planus, has completed, sponsored by Nita Chainani Wu.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week follow-up. The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels.
Primary Outcome
Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 wh
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Curcuminoids
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
What the finished NCT00525421 record still lists
NCT00525421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, roughly in line with the 19-participant average among 3 other Oral Lichen Planus trials with a reported enrollment target.
The record links to 1 condition, with Oral Lichen Planus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00525421 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00525421 about?
NCT00525421 is a clinical study titled "A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus". A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subject...
What is the current status of trial NCT00525421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2007-10. Estimated completion is 2009-02.
What conditions does trial NCT00525421 study?
This clinical trial studies the following conditions: Oral Lichen Planus.
What interventions are being tested in trial NCT00525421?
The interventions under investigation include: Placebo (DRUG), Curcuminoids (DRUG).
Who is sponsoring clinical trial NCT00525421?
This trial is sponsored by Nita Chainani Wu, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00525421 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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