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

NCT07141446 | Completed Phase 1 DMC

• 1 other identifier: GDCH/IEC/I-2024(04)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Lichen Planus

Keywords

Oral Lichen Planus; Neem; Triamcinolone acetonide; corticosteroid; clinical trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Hospital Anxiety and Depression Scale

  From Enrollment to the end of 3 months

Study Arms (2)

Neem

EXPERIMENTAL

Drug: Neem gel

Triamcinolone Acetonide

ACTIVE COMPARATOR

Drug: Triamcinolone Acetonide

Interventions

Neem gel DRUG

1.5% Neem Gel in orabase formulation, twice daily application for 3 months

Neem

Triamcinolone Acetonide DRUG

0.1% oral paste to be applied twice daily for 3 months

Triamcinolone Acetonide

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Goa Dental College: lead

Study Sites (1)

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

Goa, Bambolim, 403202, India

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: February 5, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 28, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)