Curcumin and Nanocurcumin in Oral Aphthous Ulcer

Recurrent Aphthous Stomatitis Clinical Trial

Official title:

Comparison of Curcumin and NanoCurcumin in Recurrent Aphthous Stomatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385979
• Other study ID #: SBMU1
• Status: Completed
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Recurrent Aphthous Stomatitis
• Recurrent Aphthous Ulcer
• Stomatitis
• Stomatitis, Aphthous

Intervention

Other:
• Gel
containing herbal Curcumin or NanoCurcumin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mahinbakhshi@Sbmu.Ac.Ir	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one week
Primary	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)	one week