Curcumin and Nanocurcumin in Oral Aphthous Ulcer

NCT ID: NCT04385979

Last Updated: 2020-05-13

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

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2020-03-01

Brief Summary

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Recurrent aphthous ulcer is a painful inflammatory lesion with a high prevalence. Since the etiology is not clear, several strategies have been proposed to reduce pain and severity of its symptoms. Today, curcumin is considered as an herbal medicine with anti-inflammatory properties. Treatment or control of various inflammatory diseases has been proposed, but its low solubility in water has reduced bioavailability, while the use of nanoparticle pharmaceutical techniques has been able to solve these problems. Therefore, the aim of the present study was to evaluate the clinical efficacy of a new topical curcumin gel with nano-technology and compare it with 2% curcumin gel in patients with recurrent aphthous ulcers.

This randomized clinical trial was performed on 48 patients assigned to two groups (nano-curcumin gel) and (curcumin gel). Before treatment, the size of the wound and VAS were measured. After intervention, the two variables were measured again on the fourth and seventh days , then the amount of improvement was quantitatively and qualitatively compared in the two groups and a significant level of less than 0.05 was considered.

Detailed Description

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Conditions

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Recurrent Aphthous Ulcer Recurrent Aphthous Stomatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Curcumin

%2 Curcumin gel

Group Type ACTIVE_COMPARATOR

Gel

Intervention Type OTHER

containing herbal Curcumin or NanoCurcumin

Nanocurcumin

%1 NanoCurcumin gel

Group Type ACTIVE_COMPARATOR

Gel

Intervention Type OTHER

containing herbal Curcumin or NanoCurcumin

Interventions

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Gel

containing herbal Curcumin or NanoCurcumin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with minor and recurrent aphthous ulcer lesions within 48 hours and Aphthous like Lesions

Exclusion Criteria

* Wounds are in inaccessible areas (such as posterior palate). If a person suffers from systemic disease (through questioning the patient) Patients with turmeric allergy and any type of gel used in this study. Pregnant or lactating women .. accompany with other mucosal lesions. Do not take any other medicine while taking intervention Major or herpeti form of aphthous ulcer
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mahin Bakhshi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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[email protected]

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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SBMU1

Identifier Type: -

Identifier Source: org_study_id

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