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IRCT20250503065570N1 IRCT 2025-07-22 Arak University of Medical Sciences Investigating the effect of cranberry medicine on the prevention of dysuria caused by Urodynamic study A Randomized Clinical Trials Investigating the effect of cranberry medicine on the prevention of dysuria caused by Urodynamic study A Randomized Clinical Trials 2025-07-26 anticipated 74 Complete https://irct.ir/trial/83254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the random permutation block method will be used for randomization. For this purpose, a block of 6 will be used. In each block, the letter I (Intervention) is written on three cards and the letter P (Placebo) is written on three cards. To hide the cards, they are placed in an envelope and turned over several times so that their order is not clear. As each participant enters, a card is selected for him and the selected card is set aside. This is done for the next five patients until 6 people are identified. Then, randomization will be done in the same way for the other groups of 6 people to achieve the desired sample size, Blinding description: This study is a double-blind study in which neither the researcher nor the patient knows which treatment is assigned to the patient. The statistical consultant performs block randomization and assigns a code to each drug, contacts the pharmacy and announces the type of drug and the code, and then the pharmacy writes the code on the drug and gives it to the patient for whom the specialist doctor has prescribed cranberry. This study has a placebo and after obtaining informed consent from the patient, some patients are given a placebo and some are given the cranberry drug itself. 3 Dysuria caused by bladder aerodynamics. Intervention 1: Intervention group: Each capsule of Cranfix contains approximately 500 mg of cranberry extract. Since participants are instructed to take 2 capsules per day (one every 12 hours), the total daily dose will be 2 capsules × 500 mg, 1000 mg of cranberry extract per day. Over a 1-week period, they will take a total of 7000 mg of cranberry extract. In order to emphasize the continued use of the capsules, daily telephone calls will be made to the patients in some cases. Cranfix Cranberry Fruit Extract (Vaccinium Macrocarpon L) capsules, 500 mg dose, are manufactured in Gol Daru Company, Isfahan, Soffe Industrial Estate, Iran. Intervention 2: Control group: The placebo control group will be given the same 500 mg cranberry capsule as the original drug and at the same time. Each placebo capsule of Cranfix is approximately 500 mg. Since participants are instructed to take 2 capsules per day (one every 12 hours), the total daily dose of 2 capsules × 500 mg will be 1000 mg per day. Over a 1-week period, they will take a total of 7000 mg. In order to emphasize the continuous use of the placebo capsule, daily telephone calls will be made to the patients in some cases. The placebo capsule of Cranfix Cranberry Fruit Extract (Vaccinium Macrocarpon L), 500 mg, is manufactured in Gol Daru Company, Isfahan, Soffe Industrial Estate, Iran. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information available.
public Maryam Shokrpour
Alam Al-Hoda Street . Shahid Shiroodi Street
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 info@arakmu.ac.ir Arak University of Medical Sciences scientific Maryam Shokrpour
Sina Rezaei Ashtiani Hospital . Next to the Faculty of Medicine . Basij Square.
Arak Iran (Islamic Republic of) 3848176941 +98 86 3836 0000 it_amiralmomenin@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) People for whom a bladder tape has been requested Age over 18 years old Absence of previously diagnosed anatomical abnormalities of the urinary tract No symptoms of vaginitis or cystitis Absence of asymptomatic bacteriuria 18 years no limit Female Patient's unwillingness to take medication R30.0 Dysuria Treatment - Drugs Treatment - Drugs Intervention group: Each capsule of Cranfix contains approximately 500 mg of cranberry extract. Since participants are instructed to take 2 capsules per day (one every 12 hours), the total daily dose will be 2 capsules × 500 mg, 1000 mg of cranberry extract per day. Over a 1-week period, they will take a total of 7000 mg of cranberry extract. In order to emphasize the continued use of the capsules, daily telephone calls will be made to the patients in some cases. Cranfix Cranberry Fruit Extract (Vaccinium Macrocarpon L) capsules, 500 mg dose, are manufactured in Gol Daru Company, Isfahan, Soffe Industrial Estate, Iran. Control group: The placebo control group will be given the same 500 mg cranberry capsule as the original drug and at the same time. Each placebo capsule of Cranfix is approximately 500 mg. Since participants are instructed to take 2 capsules per day (one every 12 hours), the total daily dose of 2 capsules × 500 mg will be 1000 mg per day. Over a 1-week period, they will take a total of 7000 mg. In order to emphasize the continuous use of the placebo capsule, daily telephone calls will be made to the patients in some cases. The placebo capsule of Cranfix Cranberry Fruit Extract (Vaccinium Macrocarpon L), 500 mg, is manufactured in Gol Daru Company, Isfahan, Soffe Industrial Estate, Iran. Dysuria after bladder taping. Timepoint: Within 24 to 72 hours, first call within 24 hours and second call 72 hours later. Method of measurement: Checklist and questions. Arak University of Medical Sciences Approved 2025-04-20 Ethics Committee of Arak University of Medical Sciences Alam Al-Hoda Street . Shahid Shiroodi Street Arak Markazi Iran (Islamic Republic of)