Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226174
Status:
TERMINATED
Last Update Posted:
2023-11-08
First Post:
2005-09-22
Brief Title:
A Randomized Placebo-controlled Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus
Detailed Description:
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None