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
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Aphthous Ulcer focused on measuring Recurrent Aphthous Stomatitis, Curcumin, Nanocurcumin, management
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
Sites / Locations
- Mahinbakhshi@Sbmu.Ac.Ir
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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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