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

NCT ID: NCT07141446

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neem

Group Type EXPERIMENTAL

Neem gel

Intervention Type DRUG

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

Triamcinolone Acetonide

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

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

Interventions

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Neem gel

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

Intervention Type DRUG

Triamcinolone Acetonide

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goa Dental College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Medhana Mangaonker

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Goa, Bambolim, India

Site Status

Countries

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India

Other Identifiers

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GDCH/IEC/I-2024(04)

Identifier Type: -

Identifier Source: org_study_id

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