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IRCT20190624043991N22 IRCT 2023-11-19 Tehran University of Medical Sciences Investigating the effect of oral theophylline on complications caused by double J Investigating the effect of oral theophylline on complications caused by double J: A Double Blind Clinical Trial 2024-01-31 anticipated 60 Complete https://irct.ir/trial/72779 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a double-blind, randomized clinical trial. The researcher and the participant will not know about the randomization method. For randomization, the balanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the Sealdenvelop online site, the generated sequence will be available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected, and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the group (Double G plus placebo: 30 patients) or (Double G plus theophylline: 30 patients), Blinding description: The present study is a double-blind, randomized clinical trial study. The researcher and the participant will not know how to be placed in the control or intervention groups.The present study is a double-blind, randomized clinical trial study. The researcher and the participant will not know how to be placed in the control group: Double G plus placebo, and the treatment group: Double G plus theophylline.Placebo, a capsule containing sugar resembling a probiotic capsule, is prescribed for 4 weeks. 3 Ureteral stone. Intervention 1: Treatment group, Double G, along with the use of Teolite with the generic name of Theophylline Retard with a dose of 200 mg, Obeidi Pharmaceutical Company, 30 tablets, one daily for one month. Intervention 2: Treatment group, double G, and placebo (a capsule containing sugar that looks similar to a probiotic capsule and is prescribed for 4 weeks),Obeidi Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Demographic information anonymously When: One year after publication To whom: En Researchers working in academia, physicians, surgeons and hospitals Conditions: En Any analysis can be done with the consent of the main researcher Where to obtain: Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 How to obtain: En After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy. Comments:
public Dr Akram Mirzaei
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Mohammad Kazem Aghamir
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mkaghamir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing trans ureteral lithotripsy Patients under the endoscopic ureter For other cases that have a bleeding effect, double G is installed for them. Written and informed consent from patients 18 years 40 years Both Symptoms of prostatitis/ asthma/ being a smoker Diabetes Gastrointestinal discomfort Insomnia and tremors Taking potassium-sparing diuretics Taking digoxin in patients with heart problems Taking levodopa Taking calcium supplements at the same time/ Taking spironolactone tablets Previous history of hyperkalemia Taking triamterene Taking tablets Amiloride High blood potassium and pregnancy N21 Calculus of lower urinary tract Treatment - Drugs Placebo Treatment group, Double G, along with the use of Teolite with the generic name of Theophylline Retard with a dose of 200 mg, Obeidi Pharmaceutical Company, 30 tablets, one daily for one month Treatment group, double G, and placebo (a capsule containing sugar that looks similar to a probiotic capsule and is prescribed for 4 weeks),Obeidi Pharmaceutical Company Investigating the double J infection brought on by double J stent placement and theophylline usage or non-use. Timepoint: Immediately after leaving double J stent. Method of measurement: Laboratory diagnosis. Hematuria after surgery from the operation site. Timepoint: Immediately after surgery. Method of measurement: The number of wet gases. Tehran University of Medical Sciences Approved 2023-04-15 Ethics Committees in Medical Medical Research Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)