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IRCT20191228045911N1 IRCT 2020-03-02 Tehran University of Medical Sciences The effect of date palm pollen on sexual desire and potency of cardiac patients DPP Evaluation of the effect of Date Palm Pollen (D.P.P) on sexual desire and potency of male patients after coronary artery bypassgraft surgery 2019-09-03 anticipated 114 Complete https://irct.ir/trial/45968 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients to study groups is done using Block Randomization method. Samples are divided into intervention and placebo groups based on the random sequence generated by the statistic consultant. A random sequence is generated by random four-way blocks; each block represents four participants. Distribution of placebo and interventions in each block is random but under a condition that there must be two placebos and two interventions in each block. Using this method, the number of samples assigned to each of the groups are equal, so in cases that mid-term analysis is required, the equal number of samples for both groups are available, Blinding description: Medication and placebo are identical in terms of appearance an packaging, only differentiated through the proprietary codes set by the pharmacist on the box of medicine. The patient and the prescribing researcher are not aware of the code. The outcomes of the study are prepared by the researcher who is unaware of the grouping and is blind to the groups and type of medications. 3 Condition 1: Sexual dysfunction. Condition 2: Low sexual desire. Intervention 1: Intervention group: 3 grams sachet of Shahani date palm pollen of Jahrom, containing fine Powder of date palm pollen, one in the morning and one in the night, for 8 weeks. Intervention 2: Control group: 3 grams sachet of Avisel containing fine Powder of Avisel, one in the morning and one in the night, for 8 weeks. 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 Because the study is not finished yet
public Hamed Hooshang Malamiri
College of Iranian medicine, No. 27 , Shahid ُSarparast-e-shomali street
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 6527 mirzahamed69@gmail.com Tehran University of Medical Sciences scientific Hamed Hooshang Malamiri
College of Iranian medicine, No. 27, Shahid Sarparast-e-Shomali street
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 6527 mirzahamed69@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing coronary artery bypass surgery Sexual dysfunction IIEF score less than 50 Ejection fraction greater than 30% Male Gender Age : 40 to 70 years old 40 years 70 years Male Creatinine over 1.5 AST and ALT are more than twice the normal History or Prostate Cancer CABG again Active inflammatory diseases Myocardial infarction in the past 6 months EF less than 30% Uncontrolled thyroid disorders Major depression Coldness of marital relations that leads to inability to have sex. History of allergies to pollen of flowers and plants N52 F52.0 Male erectile dysfunction Hypoactive sexual desire disorder Treatment - Drugs Treatment - Drugs Intervention group: 3 grams sachet of Shahani date palm pollen of Jahrom, containing fine Powder of date palm pollen, one in the morning and one in the night, for 8 weeks Control group: 3 grams sachet of Avisel containing fine Powder of Avisel, one in the morning and one in the night, for 8 weeks Erectile function. Timepoint: Before intervention, week 4 and week 8 after intervention. Method of measurement: International Index of Erectile Function Questionnaire. Sexual desire. Timepoint: Before intervention, week 4 and week 8 after intervention. Method of measurement: Halbert index of sexual desire. Tehran University of Medical Sciences Approved 2020-02-10 Vice-chancellor in research affairs- Tehran university of medical Sciences Vice Chancellor for Research and Technology, Sixth Floor, Ghods Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)