1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drbakyavenkatesanmds@gmail.com].
   


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disorder associated with pain, burning sensation, and erosive oral lesions, which significantly affect patients’ quality of life. Conventional management primarily involves topical corticosteroids such as triamcinolone acetonide; however, their long-term use is associated with adverse effects, necessitating safer and effective alternatives. Natural agents like Nigella sativa and curcumin possess anti-inflammatory, antioxidant, immunomodulatory, and antineoplastic properties and have shown promising results in oral mucosal diseases.

This randomized controlled clinical trial aims to assess and compare the efficacy of 10% topical Nigella sativa oromucosal paste and 10% topical curcumin oromucosal paste with 0.1% topical triamcinolone acetonide in the management of symptomatic oral lichen planus. A total of 90 clinically and histopathologically confirmed OLP patients will be randomly allocated into three groups (30 patients each). Group A will receive 10% Nigella sativa paste, Group B will receive 10% curcumin paste, and Group C will receive 0.1% triamcinolone acetonide paste, applied 3–4 times daily for four weeks.

Patients will be evaluated weekly for subjective symptoms (pain and burning sensation) using the Visual Analog Scale (VAS) and objective clinical improvement using the Thongprasom grading system. The outcomes of this study may help establish Nigella sativa and curcumin as effective and safer therapeutic alternatives or adjuncts to conventional corticosteroid therapy in the management of symptomatic oral lichen planus.