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IRCT20190308042966N1 IRCT 2019-10-30 Mashhad University of Medical Sciences Effect of topical nanoliposomes gel containing curcumin (Sinanumin) in improving stomatitis aphthous in patients with Behcet's disease compared to Triamcinolone Acetonide Effect of topical nanoliposomes gel containing curcumin (Sinanumin) in improving stomatitis aphthous in patients with Behcet's disease compared to Triamcinolone Acetonide 2019-12-22 anticipated 100 Complete https://irct.ir/trial/42462 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: The patient is unaware of the treatment and the blinding of the analyzer and the patient (double blind) is performed. 3 Behcet's disease - Recurrent Oral aphthous. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Seyed farzam Mircheraghi
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN.
Mashhad Iran (Islamic Republic of) 9177817022 +98 51 3870 0349 mircheraghif961@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed farzam Mircheraghi
International Students Admission Committee, International Office, Chancellory Building, Mashhad University of Medical Sciences, Mashhad, P.O. Box: 91735-951, I. R. IRAN.
Mashhad Iran (Islamic Republic of) 9177817022 +98 51 3870 0349 mircheraghif961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients between the age of 14 and 50 years with sufficient literacy and knowledge to provide explanations 14 years 50 years Both 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 K12.0 M35 Behcet's disease Treatment - Drugs Treatment - Drugs 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. 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. Mean pain score between two groups after intervention. Timepoint: Day 0, 3 and 7. Method of measurement: Caliper Vernier Ruler. Mashhad University of Medical Sciences Approved 2019-05-28 Research Ethics Committee of School of Medicine- Mashhad University of Medical Sciences University Street, Central Building of Mashhad University of Medical Sciences (Qurishi) Mashhad Razavi Khorasan Iran (Islamic Republic of)