Clinical Trial: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus
Brief Summary: The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.
Detailed Summary:
Lichen planus is a chronic mucocutaneous, immunologic disease. It can affect the oral mucosa, causing changes that can range from white lace-like patterns on the mucosa, to red atrophic changes to the presence of ulcerations. Symptoms can range from none to severe soreness that greatly interferes with eating. The etiology of lichen planus is not known, and because the tissue damage is mediated by immune cells, lichen planus is considered to be an autoimmune disease. Currently, the most common treatment for oral lichen planus (OLP) is use of systemic and/or topical steroids. These medications though efficacious have side-effects that limit the effectiveness of these treatments.
Tumeric, which comes from the plant curcuma longa, has been used for centuries in Ayurveda (Indian traditional medicine) for its anti-inflammatory properties. In western scientific studies, including invitro studies, animal studies and human studies, components of tumeric called curcuminoids (which include, curcumin (diferuloyl methane), demethoxycurcumin, and bisdemethoxycurcumin) have been found to have anti-inflammatory properties and to be very safe, with few side-effects even at high doses.
The objective of this study is to determine whether curcuminoids, which are safe, non-toxic compounds, can be used to control the signs and symptoms of OLP, a disease which can have serious morbidity, and for which current treatment has significant side-effects. If found to be efficacious, these tumeric extracts will aid patients with OLP in reducing symptoms and therefore the morbidity associated with OLP.
Sponsor: University of California, San Francisco
Current Primary Outcome: Change in symptom scores at 7 weeks
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in clinical signs at one, four and seven weeks
- Change in symptom scores at one and four weeks
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: September 22, 2005
Date Started: February 2003
Date Completion: September 2004
Last Updated: September 22, 2005
Last Verified: September 2005
