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IRCT20221213056808N1 IRCT 2023-04-17 Gorgan University of Medical Sciences investigation and Comparison of the effect of Daflon and pentoxifylline in the treatment of patients with chronic venous insufficiency investigation and Comparison of the effect of Daflon and pentoxifylline in the treatment of patients with chronic venous insufficiency 2023-02-20 anticipated 100 Complete https://irct.ir/trial/67790 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of samples to groups will be done with a table of random numbers. In this way, the substitutions of ABC-ACB-BAC-BCA-CAB-CBA and assigning code 1 to 6 will be done. In the table of random numbers, a single-digit number will be randomly selected and moved down, and with each number obtained, the corresponding place of those samples will be assigned to groups. If the numbers zero, 7, 8 and 9 are obtained, they will not be considered, Blinding description: Patients will not know their allocation to study groups. Allocation of the samples to the studied groups will be done by the respected vascular surgeon and based on the table of random numbers, and the student will not know about it either. 1-2 Patients with chronic venous insufficiency. Intervention 1: The first intervention group: patients who entered the study according to the inclusion criteria and were treated with pentoxifylline tablets (from Farabi company) at a dose of 400 mg three times a day for 6 months. Intervention 2: The second intervention group: patients who entered the study according to the inclusion criteria and were treated with Daflon tablets 500 mg twice a day for 6 months. Yes - There is a plan to make this available What will be shared: After conducting a study on patients who have taken two drugs, Daflon and Pentoxifylline, for a certain period of time, all the classified data can be shared after de-identifying the patients. When: The access period starts 1 month after the results are published To whom: The data will be available to all researchers working in academic and scientific institutions as well as people working in the industry. Conditions: There is no specific limitation. Where to obtain: Dr Iman Heidari mobile:09113222421 email: imanheidari72@gmail.com How to obtain: The reason for the request regarding the data and the subject of study should be emailed to the desired address, as soon as it is reviewed, it will be provided to the requester in the shortest possible time. Comments:
public Iman Heidari
Farhang building ; Edalat 61 ; Naharkhoran Boulevard
Gorgan Iran (Islamic Republic of) 4917845653 +98 17 3252 7741 Imanheidari72@gmail.com Gorgan University of Medical Sciences scientific Pezhman Kharazm
Surgery Department Office ;Shahid Nabawi Building; fifth floor; 5 Azar Hospital
Gorgan Iran (Islamic Republic of) 4917761551 0098 17 3153366 Pezhmankh@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Chronic venous insufficiency disease with class C2 and more according to CEAP criteria Consent to take medicine Ability to communicate no limit no limit Both Patients who are candidates for surgery Patients who do not take medicine I87.2 Venous insufficiency (chronic) (peripheral) Treatment - Drugs Treatment - Drugs The first intervention group: patients who entered the study according to the inclusion criteria and were treated with pentoxifylline tablets (from Farabi company) at a dose of 400 mg three times a day for 6 months. The second intervention group: patients who entered the study according to the inclusion criteria and were treated with Daflon tablets 500 mg twice a day for 6 months. CEAP( classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P)) Score. Timepoint: At the beginning of the study and 6 months after taking the drug. Method of measurement: C0: no obvious features of the disease: C1: spider veins C2: obvious varicose veins: C3: edema: C4: eczema and skin discoloration: C5: healing wounds C6: active wounds with exudation. Venous Clinical Severity Score(vcss score). Timepoint: At the beginning of the study and 6 months after taking the drug. Method of measurement: Pigmentation: 0-2 Vascularity: 0-5 Pliability: 0-5 Height: 0-3. Gorgan University of Medical Sciences Approved 2023-01-01 Ethics committee of Golestan University of Medical Sciences 5 Azar Street, 5 Azar Hospital, Surgery Department Gorgan Golestan Iran (Islamic Republic of)