Assessment of the Efficacy of Topical Curcumin in Treatment of Oral Lichen Planus

NCT ID: NCT06605911

Last Updated: 2024-09-20

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

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-01

Brief Summary

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to evaluate the therapeutic impact of curcumin as Alternative or Complementary to Triamcinolone Acetonate in Treatment of Oral Lichen Planus.

Detailed Description

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Background: Oral lichen planus (OLP) is a chronic inflammatory disorder affecting the mucous membranes, believed to be an immune-mediated condition. Its persisting nature can lead to extended discomfort for those affected. The primary symptoms are pain and a burning sensation, with a potential risk of malignancy if not properly managed, necessitating lifelong clinical monitoring. Presently, OLP is considered a significant challenge due to the absence of a definitive cure.

Patients \& patients: Thirty patients with oral lichen planus were divided into three groups, 10 patients each: Group A: ten patients with OLP were received topical triamcinolone acetonide. Group B: ten patients with OLP were received topical curcumin. Group C: ten patients with oral lichen planus were received topical triamcinolone acetonide combiend with topical curcumin. For six weeks. Each patient was examined at baseline,1 and 3months of therapy. Pain was scored using the visual analogue scale. Salivary level of interleukin 1 were estimated at baseline,1and 3 months' evaluation periods.

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

thirty patients with oral lichen planus were divided into three groups, 10 patients each: Group A: ten patients with OLP were received topical triamcinolone acetonide. Group B: ten patients with OLP were received topical curcumin. Group C: ten patients with oral lichen planus were received topical triamcinolone acetonide combiend with topical curcumin. For six weeks. Each patient was examined at baseline, 2, weeks and 1 and 3months of therapy. Pain was scored using the visual analogue scale. Salivary level of interleukin 1 were estimated at baseline, 1 and3 months' evaluation periods.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical triamcinolone acetonide

Group I

Group Type EXPERIMENTAL

topical triamcinolone acetonide

Intervention Type DRUG

ten patients with OLP were received topical triamcinolone acetonide four times per day for six weeks

Topical curcumin

Group II

Group Type EXPERIMENTAL

Topical Curcumin

Intervention Type DRUG

Ten patients with OLP received topical curcumin four times per day for six weeks.

Topical triamcinolone acetonide combiend with topical curcumin

Group III

Group Type ACTIVE_COMPARATOR

topical triamcinolone acetonide combiend with topical curcumin

Intervention Type DRUG

Ten patients with OLP received a combination of topical triamcinolone acetonide and topical curcumin four times per day for six weeks.

Interventions

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topical triamcinolone acetonide

ten patients with OLP were received topical triamcinolone acetonide four times per day for six weeks

Intervention Type DRUG

Topical Curcumin

Ten patients with OLP received topical curcumin four times per day for six weeks.

Intervention Type DRUG

topical triamcinolone acetonide combiend with topical curcumin

Ten patients with OLP received a combination of topical triamcinolone acetonide and topical curcumin four times per day for six weeks.

Intervention Type DRUG

Other Intervention Names

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Group I Group II Group III

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of OLP

Exclusion Criteria

* Any systemic autoimmune disease
* Any current use of anticoagulant or antiplatelet agents (curcumin has inhibitory effects on platelet aggregations).
* Any topical, local or systemic corticosteroids therapy during the past 3 months.
* lichenoid reaction from medications.
* Pregnant or lactation women.
* smokers
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaymaa Hussein Rafat Kotb

OTHER

Sponsor Role lead

Responsible Party

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Shaymaa Hussein Rafat Kotb

Assistant lecturer of Oral Medicine ,periodontology ,oral Diagnosis & Dental Radiology ,Sphinx university

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed F Edrees, prof

Role: STUDY_DIRECTOR

Al-AzharU

Locations

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Al-Azhar university

Asyut, Ass, Egypt

Site Status

Countries

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Egypt

Related Links

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Other Identifiers

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AUAREC20240004-15

Identifier Type: -

Identifier Source: org_study_id

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