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IRCT20240203060886N1 IRCT 2024-02-22 Shahre-kord University of Medical Sciences Evaluating the effect of tropical sildenafil gel on incidence and severity of Raynaud’s Phenomenon Attacks in patients with systemic sclerosis: A double blinded randomized clinical trial Evaluating the effect of tropical sildenafil gel on incidence and severity of Raynaud’s Phenomenon Attacks in patients with systemic sclerosis: A double blinded randomized clinical trial 2024-03-05 anticipated 70 Complete https://irct.ir/trial/75400 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By simple randomization, an envelope with a hidden card (35 group 1 and 35 group 2) will be selected for each person eligible to enter the study, and each patient will be assigned to the intervention or placebo group. Only the statistician and the clinical pharmacist will know the contents of each card and medicine received, and the shape, smell, color and other physical properties of the placebo will be similar to the medicine received by the intervention group, Blinding description: This study will be done in a double-blind manner; In this way, first, all gels (sildenafil and placebo, which are completely similar in terms of shape, color, smell, and consistency) will be coded by the clinical pharmacist and will be delivered to the researcher following the patient based on the block in which the patient is located. . Each patient will be followed up with a code that is not known about the content of the medicine he received until the end of the study. 3 systemic sclerosis. Intervention 1: Intervention group: Taking Sildenafil 1% gel 15 grams (under the brand name Erecgel produced by Pishgam Daru Novin Pharmaceutical Company) every 8 hours. Intervention 2: Control group: Placebo consumption (the base of the placebo made by the pharmaceutical company will include isopropyl myristate, surfactant and co-surfactant and distilled water, and in terms of shape, consistency, color and smell are the same as Sildenafil) every eight hours. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published When: The access period will start 6 months after the results are published To whom: Our data will only be available to researchers working in academic and scientific institutions . Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address alireza_rostamian@yahoo.com or the contact number 00989356824034 How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Alireza Rostamian
Parastar street
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 5055 alireza_rostamian@yahoo.com Shahre-kord University of Medical Sciences scientific Mohammad Mosavi
Parastar street
Shahrekord Iran (Islamic Republic of) 8816754633 0098383220016 m_mousavi50@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Age over 18 and under 75 years Patients with systemic sclerosis diagnosed by ACR criteria or LeRoy و Medsger Willingness to participate in the clinical trial Absence of MI, stroke or cardiac arrhythmia in recent 6 month Skin involvement limited to fingers, hands, face, forearms and feet 18 years 75 years Both History of CKD (Creatinine clearance under ۳۰ ml/minute) or cirrhosis (Child-Pugh class C) Overlap syndrome Hypersnsitivity to topical sildenafil M34 Systemic sclerosis [scleroderma] Treatment - Drugs Placebo Intervention group: Taking Sildenafil 1% gel 15 grams (under the brand name Erecgel produced by Pishgam Daru Novin Pharmaceutical Company) every 8 hours Control group: Placebo consumption (the base of the placebo made by the pharmaceutical company will include isopropyl myristate, surfactant and co-surfactant and distilled water, and in terms of shape, consistency, color and smell are the same as Sildenafil) every eight hours Severity of pain. Timepoint: Measurement of pain severity before the intervention and 2 and 6 weeks after the intervention. Method of measurement: Visual Analogue Scale (VAS) Questionnaire. Quality of life. Timepoint: Measuring different aspects of quality of life before the intervention and 2 and 6 weeks after the intervention. Method of measurement: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF). Capiloroscopy of the nail bed of patients. Timepoint: before the intervention and 2 and 6 weeks after the intervention. Method of measurement: nailfold capiloroscope. Shahre-kord University of Medical Sciences Approved 2024-01-03 Ethics Committee of the School of Medicine, Shahrekord University of Medical Sciences Headquarters of Shahrekord University of Medical Sciences,Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran Shhahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)