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NCT Number: NCT07141446

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

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.

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Key information

Conditions

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

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Goā, Bambolim, 403202, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neem gel

Drug

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

Triamcinolone Acetonide

Drug

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

Primary outcomes

  1. Visual Analogue Scale

    Time frame: From enrollment to the end of 3 months

    Burning sensation will be evaluated with Visual Analogue scale

  2. Thongprasom's Score

    Time frame: From enrollment to the end of the 3 months

    clinical severity of lesion

  3. OLP Disease Severity Score

    Time frame: From enrollment to the end of 3 months

    Site, size and severity of lesion

Secondary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: From Enrollment to the end of 3 months

    Anxiety and depression evaluation among patients

Sponsors and collaborators

Lead sponsor

Goa Dental College

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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