Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus.

Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus: A Randomized Controlled Trial.

The goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are:

To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral Lichen Planus (OLP) as a topical treatment modality for patients with OLP,

Researchers will compare Neem to a corticosteroid (a standard treatment for Oral Lichen Planus) to see if Neem works to treat Oral Lichen Planus.

Participants:

In experimental group were given Neem Gel in Orabase formulations and control group with topical Triamcinolone acetonide oral paste to be used twice every day for 3 months Visit the clinic once every month for checkups.

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Neem gel; Drug: Triamcinolone Acetonide

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Bambolim
    • Goa, Bambolim, India, 403202
      • Department of Oral Medicine and radiology, Goa Dental College and Hospital, Bambolim Goa India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with clinical & histopathological diagnosis of OLP.
• Patient above 20 years of age.
• Patient willing to participate in the study with informed consent.
• Patient with recalcitrant OLP.

Exclusion Criteria:

• Patient with known allergic reaction to Triamcinolone Acetonide or Neem.
• Patients with lichenoid lesions.
• Patients with associated cutaneous lesions.
• Pregnant or lactating females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neem	Drug: Neem gel; 1.5% Neem Gel in orabase formulation, twice daily application for 3 months
Active Comparator: Triamcinolone Acetonide	Drug: Triamcinolone Acetonide; 0.1% oral paste to be applied twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Burning sensation will be evaluated with Visual Analogue scale	From enrollment to the end of 3 months
Thongprasom's Score	clinical severity of lesion	From enrollment to the end of the 3 months
OLP Disease Severity Score	Site, size and severity of lesion	From enrollment to the end of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	Anxiety and depression evaluation among patients	From Enrollment to the end of 3 months

Collaborators and Investigators

• Sponsor: Goa Dental College

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: August 19, 2025
• First Posted (Estimated): August 26, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: clinical trial; corticosteroid; Oral Lichen Planus; Triamcinolone acetonide; Neem
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus; Lichen Planus, Oral; Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide
• Other Study ID Numbers: GDCH/IEC/I-2024(04)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No