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IRCT20200106046023N1 IRCT 2020-03-20 Oroumia University of Medical Sciences Assessment of the botulinum toxin type A effect on Intensified Raynauds Phenomenon in Sclerodermic patients Assessment of the botulinum toxin type A effect on Intensified Raynauds Phenomenon in Sclerodermic patients 2018-09-23 anticipated 11 Complete https://irct.ir/trial/45061 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The hands of each patients were randomly divided into intervention and control groups. In this way, based on random number table, even numbers were considered as intervention hand and odd numbers as control hand, Blinding description: The patient, researcher and subject who evaluated the outcomes of study were unaware from intervention and placebo group. 2-3 Systemic sclerosis [scleroderma]. Intervention 1: Intervention group: Fifty units of botulinum toxin A. Intervention 2: Control group: 50 units of normal saline. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. SeyedMostafa SeyeMardani
No. 14002692763., Ershad street., Modarres Blvd, Imam Khomeini hospital, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-81351 +98 44 3198 8293 Mardani.m@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. SeyedMostafa SeyedMardani
No. 1400269., Ershad street, Modarres Blvd, Imam Khomeini hospital, Urmia, Iran.
Urmia Iran (Islamic Republic of) 57157-81351 +98 44 3198 8293 Mardani.m@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with scleroderma based on ACR criteria Patients with Age over 18 years Intensified and Resistant Raynauds 18 years no limit Both A history of allergy to Botox History of myasthenia gravis disease Pregnancy and lactation Taking estrogen-containing pills in the last month History of vascular surgery and sympathectomy Consumption of Aminoglycoside Antibiotics The presence of active infection The presence of severe bleeding tendency M34 Systemic sclerosis [scleroderma] Treatment - Other Other Intervention group: Fifty units of botulinum toxin A Control group: 50 units of normal saline The Raynauds activity. Timepoint: Before intervention; one and two months after injection of botulinum toxin A. Method of measurement: The Reynolds Activity Score will be measured using a standard questionnaire consisting of 4 subsets, each rated 0-4 score. Number of new wounds. Timepoint: Before intervention; one and two months after injection of botulinum toxin A. Method of measurement: The number of new wounds in the fingers will be counted by clinical examination. The number of fingers wounds. Timepoint: Before intervention, one and two months after injection of botulinum toxin A. Method of measurement: The number of wounds in the fingers will be counted by clinical examination. Pain. Timepoint: Before intervention, one and two months after injection of botulinum toxin A. Method of measurement: Visual Analogue Scale. Oroumia University of Medical Sciences Approved 2018-09-11 Ethics committee of Urmia University of Medical Sciences No. 14000245577, Resalat street., Jahad Blvd., Urmia University of Medical Sciences., Urmia., Iran. Urmia West Azarbaijan Iran (Islamic Republic of)