Effect of topical nanoliposomes gel containing curcumin (Sinanumin) in improving stomatitis aphthous in patients with Behcet's disease compared to Triamcinolone Acetonide
Evaluation and comparison the gel effect of topical nanoliposomes containing curcumin (cyanomine) and triamcinolone acetone on oral aphthous patients
Design
Clinical trial with control group, parallel groups, double blind, randomized and phase 3 clinical trials
Settings and conduct
This study was performed on patients with Behcet's syndrome with oral aphthous who referred to Imam Reza and Ghaem hospital in Mashhad from 2018 to 2020 based on inclusion and exclusion criteria. Patients were randomly divided into two groups of 50 (group 1) (using Sinanumin nanodevelopment gel) and group 2 (using triamcinolone acetone gel). They take. On day 0, 3, 7 patients were examined for the number and size of wounds and daily pain score. Then the two groups were compared based on the results of wound size, number of ulcers, duration of wound and pain score and were statistically analyzed.
were
See also
be
Participants/Inclusion and exclusion criteria
Inclusion criteria: persons with sufficient knowledge and literacy to understand the explanations provided for treatment; patients aged between 14 and 50 years old.
Exclusion criteria: traumatic ulcer; patients with dentures; pests in inaccessible areas; patients who suffer from any systemic disease causing immunodeficiency (diabetes and ESRD ...); patients with any major disease in the past; use of any systemic treatment, including use of any type of immunosuppressive drug; patients who are allergic to curcumin at baseline or during the study; pregnant or lactating women; people who cannot continue their studies for personal or social reasons.
Intervention groups
In the intervention group, topical nanoliposomes containing curcumin (cyanomine) plus colchicine and in the control group triamcinolone acetone plus colchicine were used to improve oral aphthous patients.
Main outcome variables
Number of ulcer; size of ulcer; pain score; duration of ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190308042966N1
Registration date:2019-10-30, 1398/08/08
Registration timing:prospective
Last update:2019-10-30, 1398/08/08
Update count:0
Registration date
2019-10-30, 1398/08/08
Registrant information
Name
Seyed farzam Mircheraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 0349
Email address
mrchrgh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical nanoliposomes gel containing curcumin (Sinanumin) in improving stomatitis aphthous in patients with Behcet's disease compared to Triamcinolone Acetonide
Public title
Effect of topical nanoliposomes gel containing curcumin (Sinanumin) in improving stomatitis aphthous in patients with Behcet's disease compared to Triamcinolone Acetonide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the age of 14 and 50 years with sufficient literacy and knowledge to provide explanations
Exclusion criteria:
Traumatic oral ulcer
Patients with dentures
Aphthous in inaccessible areas
Patients who suffer from any systemic disease causing immunodeficiency (diabetes and ESRD ...)
Patients with any major disease in the past
Use of any systemic treatment, including use of any type of immunosuppressive drug
Patients who are allergic to sinanomine at baseline or during the study
Pregnant or lactating women
People who cannot continue their studies for personal or social reasons
Age
From 14 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The method used to generate random allocation sequences using a random number table using randomiz.com so that envelopes are prepared and printed by a member of the Random Numbers Research Team with the help of Randomaize.com. Will take. The envelope door will be closed and its contents not visible from the outside. Then, the purpose of the study is first explained to the person who meets the requirements, and if the person wishes to sign the informed consent form, remove the envelope and then open it and enter the intervention or control group based on the contents of the individual envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of the treatment and the blinding of the analyzer and the patient (double blind) is performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine- Mashhad University of Medical Sciences
Street address
University Street, Central Building of Mashhad University of Medical Sciences (Qurishi)
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.380
Health conditions studied
1
Description of health condition studied
Behcet's disease - Recurrent Oral aphthous
ICD-10 code
K12.0 M35
ICD-10 code description
Behcet's disease
Primary outcomes
1
Description
Mean pain score between two groups after intervention
Timepoint
Day 0, 3 and 7
Method of measurement
Caliper Vernier Ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, Sina nanomedicine gel is used.Topical nano-liposomes containing curcumin (cyanomine) were made at the Nanotechnology Research Center of Mashhad University of Medical Sciences by Dr. Mahmoud Reza Jafari. The drug is made of curcumin yellow active ingredient. intervention grou benefit from standard treatment of Behcet's oral aphthous treatment, including colchicine. On day 0, 3, 7 patients were examined for the number and size of wounds and daily pain score. On day 0 the patient was examined for the number and size of the wounds and the pain score. The longest wound diameter measured using a sterile Vernier caliper is recorded as the wound size, and pain scores are reported using the Visual Analogue Scale (VAS) of zero to 10. Patients are also examined on days 3 and 7 to check for a decrease in the number and size of wounds. Pain scores are also recorded daily.
Category
Treatment - Drugs
2
Description
Control group: In the control group is used triamcinolone acetone gel. Control group benefit from standard treatment of Behcet's oral aphthous treatment, including colchicine. On day 0, 3, 7 patients were examined for the number and size of wounds and daily pain score. On day 0 the patient was examined for the number and size of the wounds and the pain score. The longest wound diameter measured using a sterile Vernier caliper is recorded as the wound size, and pain scores are reported using the Visual Analogue Scale (VAS) of zero to 10. Patients are also examined on days 3 and 7 to check for a decrease in the number and size of wounds. Pain scores are also recorded daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital - Ghaem hospital
Full name of responsible person
Seyed Farzam Mircheraghi
Street address
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3034 5831
Email
mircheraghif961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed farzam Mircheraghi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177817022
Phone
+98 51 3870 0349
Fax
Email
mircheraghif961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed farzam Mircheraghi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177817022
Phone
+98 51 3870 0349
Fax
Email
mircheraghif961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Farzam Mircheraghi
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177817022
Phone
0098513870349
Email
mircheraghif961@mums.av.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available