The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-06-01

Brief Summary

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Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus.

* Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva.
* Compare the outcome of new preparation with the gold standard treatment (corticosteroids).

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Detailed Description

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Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope

1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week

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

SINGLE

Outcome Assessors

Outcome assessor (CS) and statistician

Study Groups

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turmeric paste

Topical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015).

Group Type EXPERIMENTAL

Turmeric paste

Intervention Type DRUG

Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University

Triamcenolone in orabase

Triamcenolone + na ploycarboxylate

Group Type ACTIVE_COMPARATOR

Triamcinolone

Intervention Type DRUG

Triamcenolone +napolycarboxylate

Interventions

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Triamcinolone

Triamcenolone +napolycarboxylate

Intervention Type DRUG

Turmeric paste

Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University

Intervention Type DRUG

Other Intervention Names

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Triamcenolone in orabase Curcumin

Eligibility Criteria

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Inclusion Criteria

* Patients who will be clinically diagnosed as having atrophic \&/or erosive oral lichen planus.
* Patients with controlled diabetes and/or controlled hypertension will be included in the study.
* Patients with no history of taking corticosteroids for the last 6 months
* Patients who agrees to take medication.

Exclusion Criteria

* Pregnant and lactating ladies.
* Patients with history of topical steroids during last 2 months \& systemic steroids during last 6 months.
* Patients with recent dental filling associated with the lesion or associated with recent drug administration.
* Patient with uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes