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IRCT20170821035817N2 IRCT 2018-03-26 Mashhad University of Medical Sciences Effects of Teucrium polium on dibetic ulcer interventional Effect of Teucrium polium on diabetic foot ulcer 2018-04-21 anticipated 60 Complete https://irct.ir/trial/26950 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The enrolled patients were randomly assigned into 2 groups according to randomized block design. To select patients, each of them is given number 1 to 60 (total sample size) according to their referral time. Then patients according to their numbers, randomly receives the ointment A or B. Teucrium polium and placebo ointment are filled in identical tube and labeled as ointment A or ointment B. Only principal investigator knows the content of the ointment labeled A or B, Blinding description: On identical tubes containing the Teucrium polium and placebo, the ointment A and ointment B are labeled. Other specifications on the labels are identical. Physician, patient, data collector and analyzer are unaware of the nature and meaning of the letters A and B on the label. Only the principal researcher knows the meaning of the letters A and B on the label. N/A Diabetes. Intervention 1: Intervention : Teucrium polium ointment dressing apply on ulcer two times a day. Intervention 2: Control: Placebo ointment dressing apply on ulcer two times a day. 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 No information
public Hasan fallah huseini
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55th Kilometer of Tehran-Gazvin Freeway, Karaj, Iran.
karaj Iran (Islamic Republic of) 31375-369 +98 26 3476 4018 huseini_fallah@yahoo.com Institute of medicinal plant scientific Hasan Fallah Huseini
Kavosh Blvd, Supa Blvd, 55th km of Tehran-Qazvin Highway, Research Complex of Jahad Daneshgahi Karaj
Karaj Iran (Islamic Republic of) 31375-369 +98 26 3476 4021 huseiniFallah@yahoo.com Institute of Medicinal Plants Iran (Islamic Republic of) Iran (Islamic Republic of) Type 1 or 2 diabetic patients suffering with 1st or 2nd degree foot ulcer 20 to 60 years old patients No vascular diseases No suffering from other chronic diseases 20 years 60 years Both Patients with progressed diabetic foot ulcers Patients with diabetic foot ulcer candidate for amputation Disabled patients Patients with renal failure (creatinine clearance above 2) Patients treated with glucocorticoids Smoker and addict patients Patients with BMI greater than 25 ٍE10, E11 Diabetes mellitus Treatment - Drugs Placebo Intervention : Teucrium polium ointment dressing apply on ulcer two times a day Control: Placebo ointment dressing apply on ulcer two times a day Healing up of diabetic foot ulcer. Timepoint: 1 month. Method of measurement: Ulcer digital photography; microbial ulcer tissue culture. Ulcer temperature. Timepoint: 1 month. Method of measurement: Digital thermometer. Institute of Medicinal plant Mashhad University of Medical Sciences Institute of Medicinal plant Approved 2017-07-30 Ethics Committee of Mashhad University of Medical Sciences. Emam Reza hospital, Daneshgah Street, Mashhad Razavi Khorasan Iran (Islamic Republic of)