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

G

Goa Dental College

Status and phase

Completed
Phase 2
Phase 1

Conditions

Oral Lichen Planus

Treatments

Drug: Triamcinolone Acetonide
Drug: Neem gel

Study type

Interventional

Funder types

Other

Identifiers

NCT07141446
GDCH/IEC/I-2024(04)

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Neem
Experimental group
Treatment:
Drug: Neem gel
Triamcinolone Acetonide
Active Comparator group
Treatment:
Drug: Triamcinolone Acetonide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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