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IRCT20260619069872N1 IRCT 2026-06-29 Karaj University of Medical Sciences Evaluation of the effect of oral theophylline on clinical symptoms of patients with cardiac syndrome X Evaluation of the Efficacy of Oral Theophylline on Clinical Symptoms of Cardiac Syndrome X at Shahid Rajaei Hospital, Karaj 2026-07-06 anticipated 46 Recruiting https://irct.ir/trial/91168 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized in a 1 to 1 ratio into the intervention or control groups using block randomization with variable block sizes of 4 and 6 The allocation sequence will be generated by an independent epidemiologist using Stata software To ensure allocation concealment the assignments will be placed in sequential numbered opaque and sealed envelopes Upon enrollment of each participant the corresponding envelope will be opened to determine the treatment assignment, Blinding description: The study is designed as a double blind clinical trial Theophylline 100mg tablets and placebos will be manufactured to be completely identical in appearance color packaging and taste Patients the investigator who collects data and the statistician who analyzes data will remain fully blinded to the group allocations until the statistical analysis is completed. 3 Cardiac Syndrome X (Microvascular Angina). Intervention 1: Intervention group: Patients in the intervention group receive oral theophylline tablets 100 mg once daily for 4 weeks. Intervention 2: Control group: Control group: Patients receive placebo tablets completely identical in appearance, color, taste, and packaging to the active drug once daily for 4 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is To protect patient confidentiality and privacy and in accordance with the ethical and legal regulations of Alborz University of Medical Sciences individual participant data will not be publicly shared and study findings will only be published as aggregate data in scientific journals
public Mostafa Kalvandi
Unit 3, Sayeh Building, No. 9, Shahid Behtoui St, Before 45-meter Kaj, Estiklal Blvd, Azimieh, Karaj
Karaj Iran (Islamic Republic of) 3154694763 +98 26 3250 7699 Mostafakal1375@gmail.com Karaj University of Medical Sciences scientific Alireza Dehghan Nayeri
School of Medicine, Alborz University of Medical Sciences Campus, Above Art University, End of West Bouali, Nobovat Sq, Karaj
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3419 8000 ama_dehghan@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of Cardiac Syndrome X with anginal chest pain and positive myocardial perfusion imaging scan Normal coronary arteries or mild coronary artery disease less than 50 percent on angiography Normal ejection fraction on echocardiography Absence of significant valvular heart disease 18 years no limit Both Coronary artery stenosis greater than 50 percent on angiography Pregnancy or lactation History of seizures or severe ventricular arrhythmias Severe asthma or severe chronic obstructive pulmonary disease Concomitant use of beta-blockers or calcium channel blockers or ranolazine I20.8 Other forms of angina pectoris Treatment - Drugs Placebo Intervention group: Patients in the intervention group receive oral theophylline tablets 100 mg once daily for 4 weeks Control group: Control group: Patients receive placebo tablets completely identical in appearance, color, taste, and packaging to the active drug once daily for 4 weeks Mean scores of the Seattle Angina Questionnaire dimensions including physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. Timepoint: At baseline before the intervention and four weeks after the initiation of the theophylline or placebo intervention. Method of measurement: Completion of the standardized international Seattle Angina Questionnaire and calculating each dimension score on a scale of 0 to 100 according to the official tool protocol. Karaj University of Medical Sciences Approved 2026-06-06 کمیته اخلاق در پژوهش دانشگاه علوم پزشکی البرز ۴۵ متری گلشهر، کوچه صفاریان، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی البرز کرج Alborz Iran (Islamic Republic of)