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IRCT20201010048984N1 IRCT 2020-10-23 Ahvaz University of Medical Sciences Effect of Grape seed oil (Grapex) on scleroderma wound healing Effect of Grape seed oil (Grapex) on wound healing in patients with scleroderma 2019-05-22 anticipated 40 Complete https://irct.ir/trial/51719 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into two groups A and B. Block randomization methods were used. The size of the block was four and in each block 2 patient in group A and 2 patient in group B were assigned. The order of groups A and B within each block was determined randomly using function (RAND) in Excel software, Blinding description: Patients and the interventionist and the person examining the results did not know what group the individuals were in, and the study was double-blind. 3 scleroderma. Intervention 1: Intervention group: Grapex 2% cream prepared from the School of Pharmacy was used twice a day for 4 weeks on the surface of the wounds. Intervention 2: Control group: The second group of placebo (cream with similar composition except the main ingredient, ie grape seed extract prepared from Ahwaz School of Pharmacy) was given with the same duration of the intervention group. 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 Maryam Ghanavati
Ahvaz, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3001 Maryam.ghanavati2020@gmail.com Ahvaz University of Medical Sciences scientific Maryam Ghanavati
Ahvaz, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3001 Maryam.ghanavati2020@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Existence of at least one active wound due to scleroderma (diffuse / limited) Age 20 to 70 years Patient satisfaction 20 years 70 years Both Existence of allergy and sensitivity to grapes and their compounds, Existence of comorbidities including diabetes, thyroid disorders, and cardiovascular disease Addiction to alcohol, cigarettes and any drugs Getting prostanoids (both inhaled and taken) for at least the last 3 months Take antibiotics 2 weeks before the start of the study Moderate to severe hepatic impairment or elevated aminotransferase levels more than 3 Existence of any kind of malignancy Pregnancy and lactation Reluctance to participate in the study M34 Systemic sclerosis [scleroderma] Treatment - Drugs Treatment - Drugs Intervention group: Grapex 2% cream prepared from the School of Pharmacy was used twice a day for 4 weeks on the surface of the wounds. Control group: The second group of placebo (cream with similar composition except the main ingredient, ie grape seed extract prepared from Ahwaz School of Pharmacy) was given with the same duration of the intervention group Wound size. Timepoint: Every 2 weeks (end of the second week and the fourth week). Method of measurement: Wound ruler. Ahvaz University of Medical Sciences Approved 2019-03-16 Ethics committee of Ahwaz Jundishapur University of Medical Sciences (AJUMS) Khuzestan Province, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)