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Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Primary Purpose

Recurrent Aphthous Ulcer, Recurrent Aphthous Stomatitis

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Gel

About this trial

This is an interventional treatment trial for Recurrent Aphthous Ulcer focused on measuring Recurrent Aphthous Stomatitis, Curcumin, Nanocurcumin, management

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

Sites / Locations

Mahinbakhshi@Sbmu.Ac.Ir

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Curcumin

Nanocurcumin

Arm Description

%2 Curcumin gel

%1 NanoCurcumin gel

Outcomes

Primary Outcome Measures

Wound size

The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.

Pain score

Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome)

Secondary Outcome Measures

Full Information

NCT ID

NCT04385979

First Posted

May 6, 2020

Last Updated

May 8, 2020

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04385979

Brief Title

Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Official Title

Comparison of Curcumin and NanoCurcumin in Recurrent Aphthous Stomatitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

July 15, 2018 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Aphthous Ulcer, Recurrent Aphthous Stomatitis

Keywords

Recurrent Aphthous Stomatitis, Curcumin, Nanocurcumin, management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin

Arm Type

Active Comparator

Arm Description

%2 Curcumin gel

Arm Title

Nanocurcumin

Arm Type

Active Comparator

Arm Description

%1 NanoCurcumin gel

Intervention Type

Other

Intervention Name(s)

Gel

Intervention Description

containing herbal Curcumin or NanoCurcumin

Primary Outcome Measure Information:

Title

Wound size

Description

The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.

Time Frame

one week

Title

Pain score

Description

Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome)

Time Frame

one week

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Mahinbakhshi@Sbmu.Ac.Ir

City

Tehran

ZIP/Postal Code

0098

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Curcumin and Nanocurcumin in Oral Aphthous Ulcer

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