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IRCT2017080435420N2 IRCT 2017-08-17 Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Evaluation of therapeutic effect of Quercus infectoria gall on pressure ulcer in patients with cerebral palsy Evaluation of therapeutic effect of Quercus infectoria gall on pressure ulcer in patients with cerebral palsy due stroke 2017-08-06 anticipated 94 Complete https://irct.ir/trial/26770 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Pressure ulcer. Intervention 1: Intervention: local application of Phenytoin cream 1% once daily in areas susceptible to ulcer (sacrum; iliac; spinal cord; elbow; waist; shoulder; auricle; buttock; heel and ankle) to the extent that cover the wound area and local application of Q. infectoria gall extract in the cream tube that is similar to placebo at 12 hours later for two weeks. Intervention 2: Control: local application of Phenytoin cream 1% once daily in areas susceptible to ulcer (sacrum; iliac; spinal cord; elbow; waist; shoulder; auricle; buttock; heel and ankle) to the extent that cover the wound area and local application of placebo in the cream tube that is similar to drug at 12 hours later for two weeks.
public Dara Dastan
school of Pharmacy, Hamadan University of Medical Science, Shaheed Fahmideh Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 1590 d.dastan@umsha.ac.ir School of Pharmacy scientific Masoud Ghiasian
School of Medicine, Hamadan University of Medical Science, Shaheed Fahmideh Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 0462 Masoud_ghiasian@yahoo.com School of Medicine Iran (Islamic Republic of) Inclusion criteria: patients with 2/5 or more of paralysis due one-way stroke and with pressure ulcer; patients who score 16 or less in Norton scale. Exclusion criteria: patient death or transfer to another health center; patient with necrotic wound due pressure ulcer at the beginning of the study; positive response to allergy test of Q. infectoria gall extract; progression of pressure ulcer to higher grades during the study. 37 years 90 years Both L89.9 Decubitus ulcer and pressure area, unspecified Treatment - Drugs Placebo Intervention: local application of Phenytoin cream 1% once daily in areas susceptible to ulcer (sacrum; iliac; spinal cord; elbow; waist; shoulder; auricle; buttock; heel and ankle) to the extent that cover the wound area and local application of Q. infectoria gall extract in the cream tube that is similar to placebo at 12 hours later for two weeks. Control: local application of Phenytoin cream 1% once daily in areas susceptible to ulcer (sacrum; iliac; spinal cord; elbow; waist; shoulder; auricle; buttock; heel and ankle) to the extent that cover the wound area and local application of placebo in the cream tube that is similar to drug at 12 hours later for two weeks. Grade of pressure ulcer. Timepoint: At baseline and then daily for two weeks. Method of measurement: Through physical examination. Assessing local reactions such as rash, hives, or redness. Timepoint: 24 hours later. Method of measurement: Through physical examination. Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences Approved 2017-07-10 Ethics committee of Hamadan University of Medical Sciences Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)