]>
IRCT20120215009014N284 IRCT 2019-06-13 Hamedan University of Medical Sciences Comparison of the effect of Carob (Ceratonia Siliqua L) and Ginseng supplementation versus placebo on spermogram parameters and sexual function in infertile men Comparison of the effect of Carob (Ceratonia Siliqua L) and Ginseng supplementation versus placebo on spermogram parameters and sexual function in infertile men: a double-blind randomized clinical trial 2019-06-10 anticipated 90 Complete https://irct.ir/trial/39886 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare nine sheets of paper, writing on thre sheets the name of the intervention 1 and on three other sheets the name of the intervention 2 and on the third three sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Male infertility. Intervention 1: Intervention group 1: Capsule 500 mg including Carob (Ceratonia Siliqua L) three times a day for 12 weeks. Intervention 2: Intervention group 2: Capsule 500 mg including Ginseng three times a day for 12 weeks. Intervention 3: Control group: Capsule 500 mg including lactose (placebo) three times a day for 12 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 It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Dr Seyedeh Zahra Masoumi
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 zahramid2001@yahoo.com Hamedan University of Medical Sciences scientific Dr Seyedeh Zahra Masoumi
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 zahramid2001@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 40 years Primary infertile men Abnormality of at least one parameter of semen Body mass index less than 30 18 years 40 years Male Chromosomal abnormalities, testicular insufficiency, varicocele, cryptorchidism Chronic diseases such as diabetes, kidney disease, infectious diseases, genital tract infection, or thyroid dysfunction Using drug or alcohol Using medications that disrupt spermatogenesis (methotrexate, nitrofurantoin, colchicine and chemotherapy) Use of pituitary suppressants (testosterone, GnRh analogues) or anti-androgens (cimetidine, spironolactone) Taking drugs result in ejaculation failure (alpha-blockers, antidepressants, phenothiazide) Taking drugs result in erection dysfunction (beta-blockers, thiazide diuretics, metoclopramides) Taking drugs such as anabolic steroids, cannabis, heroin or cocaine History of surgical procedures on the testes Contact with pesticides, heavy metals and solvents Use of antioxidant supplements in the last three months Intense physical activity Having a slimming diet N46 Male infertility Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Capsule 500 mg including Carob (Ceratonia Siliqua L) three times a day for 12 weeks Intervention group 2: Capsule 500 mg including Ginseng three times a day for 12 weeks Control group: Capsule 500 mg including lactose (placebo) three times a day for 12 weeks Assessing the spermogram parameters. Timepoint: 12 weeks after the intervention. Method of measurement: By laboratory test. Assessing sexual function. Timepoint: 12 weeks after the intervention. Method of measurement: By history taking. Hamedan University of Medical Sciences Approved 2019-05-18 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)