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CTRI Number  CTRI/2025/09/095503 [Registered on: 30/09/2025] Trial Registered Prospectively
Last Modified On: 29/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on patients with erosive oral lichen planus to see if curcumin gel plus steroid ointment works better than steroid ointment alone in reducing lesions and discomfort 
Scientific Title of Study   Efficacy of self-nano-emulsifying curcumin oral gel as an adjunct to triamcinolone acetonide in the management of erosive oral lichen planus: A Randomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aswathi AS 
Designation  Junior Resident 
Affiliation  Govt Dental College Kottayam 
Address  Dept of Oral Medicine and Radiology, Room No. 601 Govt Dental College Kottayam, Gandhinagar PO Kottayam

Kottayam
KERALA
686008
India 
Phone  8113918378  
Fax    
Email  aswathias713@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr LS Sreela 
Designation  Professor and HOD 
Affiliation  Govt Dental College Kottayam 
Address  Dept of Oral Medicine and Radiology, Room No. 601, Govt Dental College Kottayam, Gandhinagar PO Kottayam

Kottayam
KERALA
686008
India 
Phone  9447009888  
Fax    
Email  drsreelajkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr LS Sreela 
Designation  Professor and HOD 
Affiliation  Govt Dental College Kottayam 
Address  Dept of Oral Medicine and Radiology, Room No. 601, Govt Dental College Kottayam, Gandhinagar PO Kottayam

Kottayam
KERALA
686008
India 
Phone  09447009888  
Fax    
Email  drsreelajkumar@gmail.com  
 
Source of Monetary or Material Support  
Dept of Oral Medicine and Radiology, Room No. 601, Govt Dental College Kottayam, Gandhinagar PO Kottayam Kerala 686008 India  
 
Primary Sponsor  
Name  Dr Aswathi AS 
Address  Junior Resident Dept Of Oral Medicine and Radiology, Room No. 601, Govt Dental College Kottayam, Gandhinagar PO Kottayam,Kerala-686008, India Room No 601, Govt Dental College Kottayam Gandhinagar PO 686008 Govt Dental College Kottayam 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aswathi AS  Govt Dental College Kottayam  Dept of Oral Medicine and Radiology, Room No.601, Govt Dental College Kottayam, Gandhinagar PO Kottayam, Kerala-686008, India Govt Dental College Kottayam
Kottayam
KERALA 		 08113918378

aswathias713@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of the Institutional Ethics Commitee (IEC)/ Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Triamcinolone Acetonide Buccal Paste 0.1% w/w + Placebo gel  Topical application of Triamcinolone Acetonide Buccal Paste 0.1% w/w + Placebo gel on the lesions by taking small amount of paste on finger tips and applied using gentle pressure twice daily(Morning and Night).There should be a time gap of 30 minutes between application of each gel.  
Intervention  Triamcinolone Acetonide Buccal Paste 0.1% w/w + SNEDDS Curcumin Oral Gel  Topical application of Triamcinolone Acetonide Buccal Paste 0.1% w/w + SNEDDS Curcumin Oral Gel on the lesions by taking small amount of paste on finger tips and applied using gentle pressure twice daily(Morning and Night) .There should be a time gap of 30 minutes between application of each gel. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients with age above 18 yrs
2.Clinically diagnosed fresh cases of erosive Oral Lichen Planus (OLP)
3.Patients willing to participate and provide informed consent 
 
ExclusionCriteria 
Details  1.Non erosive forms of OLP (reticular, plaque, papular type)
2.History of previous treatment for OLP.
3.Clinically suspicious lesions for dysplasia or malignancy that need immediate biopsy  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
REU Score - Clinical scoring of lesion  Base line 2 weeks and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
VAS score  Baseline 2 weeks & 4 weeks 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This randomized clinical study aims to evaluate the efficacy of topical nano-emulsified curcumin as an adjunct to topical corticosteroids in the management of erosive Oral Lichen Planus (OLP), a chronic inflammatory mucocutaneous disorder with malignant potential. Although corticosteroids are the standard therapy, their limitations and side effects necessitate alternative adjunctive approaches. Curcumin, a natural antioxidant and anti-inflammatory agent, may help modulate oxidative stress, which plays a central role in OLP pathogenesis. The study will include clinically and histologically confirmed erosive OLP patients, randomized into two groups: Group A will receive topical corticosteroids alone, while Group B will receive topical corticosteroids combined with nano-emulsified curcumin. Clinical outcomes such as mouth opening, burning sensation (VAS score), and mucosal flexibility will be assessed at baseline and follow-up visits. Additionally, salivary Malondialdehyde (MDA) levels will be measured as a biomarker of oxidative stress modulation. The findings are expected to provide insights into the potential role of curcumin as a safe, effective adjunct in OLP management.
This double-blinded randomized controlled trial will be conducted at the Department of Oral Medicine and Radiology, Government Dental College, Kottayam, in collaboration with the College of Pharmaceutical Sciences, Government Medical College, Kottayam for placebo gel preparation. Patients above 18 years with newly diagnosed erosive Oral Lichen Planus (OLP) will be enrolled. Participants will be randomized into two groups: Group 1 will receive Triamcinolone acetonide 0.1% buccal paste twice daily with Self Nano-Emulsifying Curcumin gel, while Group 2 will receive Triamcinolone acetonide with placebo gel. Both groups will be instructed on oral hygiene and diet, and followed up at baseline, 2 weeks, and 4 weeks. The primary outcome will be reduction in lesion severity using the REU scoring system. Sample size was calculated as 12 per group accounting for dropouts. Randomization will use computer-generated sequences with allocation concealment, and blinding will be maintained for both patients and outcome assessors.
                                                  This study aims to determine whether adjunctive use of nano-emulsified curcumin enhances treatment outcomes of erosive OLP while minimizing steroid-associated risks. If effective, this could provide a safer, evidence-based adjunctive therapy in OLP management.
 
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