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IRCT2015092224135N1 IRCT 2016-01-28 Vice chancellor for research,Tabriz University of Medical Sciences The efficacy of Withania somnifera on spermogram in infertile men Comparison the effect of Iranian Traditional Medicine product (based on Withania somnifera) with Pentoxifylline on sperm parameters in the infertile men, triple-blind randomized Clinical trial 2016-01-07 anticipated 100 Complete https://irct.ir/trial/20435 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, randomization will be randomly done with fixed size blocks (Fixed size block randomization) and each block has a capacity of 50 people. Randomization list will be prepared by using stata13 software.In all phases of the study, the patient, the physician, the provider of drugs and collector of the data will be unaware of the medication type. 2-3 Male Infertility. Intervention 1: In control group: receiving pentoxifylline, patients will receive 800mg of pentoxifylline granules +placebo powder daily in the form of 5 capsules in morning, noon, night for 3 months. Intervention 2: In receiving traditional medicine product group(Withania somnifera ), patients will receive 5 g of this product daily in the form of 5 capsules in morning,noon, night for 3 months.
public Ramin Nasimi Doost Azgomi
School of Traditional Medicine, Central Library of Tabriz University of Medical Sciences, Tabriz University, Golgasht street, Azadi street, Tabriz
Tabriz Iran (Islamic Republic of) +98 41 3337 9529 Nasimir@tbzmed.ac.ir؛ Modir7060@yahoo.com School of Traditional Medicine, Tabriz University of Medical Sciences scientific Dr.Afshar Zomorrodi
Urology ward, Imam Reza Hospital, Golgasht street, Azadi street, Tabriz
Tabriz Iran (Islamic Republic of) 5166737618 +98 41 3335 7328 Dr_afshar@hotmail.com Imam Reza hospital, Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:Patient satisfaction؛ Men 18-45 years؛ Infertility for at least one year with unexplained Oligo+/- astheno +/- teratozoospermia according to WHO criteria؛ Nonsmoking and nonaddiction to alcohol and drugs؛ No azospermia؛ No infections, No genital anatomical abnormalities؛ No risk of varicocele؛ No history of surgery on the genital tract؛ No Systemic diseases ( cancer, thyroid diseases, liver and gall bladder diseases, renal failure, diabetes, uncontrolled hypertension, cerebral hemorrhage , retina bleeding, etc)؛ No unilateral testicular atrophy؛ No history of taking chemotherapy, corticosteroid, anticoagulation,testosterone, antiandrogen. Exclusion criteria: Smoking or any kind of drug abuse during the study؛ Intaking any other chemical or herbal infertility drug during the study؛ Make any side effects from medication؛ The need for other interventions and surgery during the study؛ The reluctance of patients to continue. 18 years 45 years Male N46 Diseases of male genital organs,Male infertility Treatment - Drugs Treatment - Drugs In control group: receiving pentoxifylline, patients will receive 800mg of pentoxifylline granules +placebo powder daily in the form of 5 capsules in morning, noon, night for 3 months In receiving traditional medicine product group(Withania somnifera ), patients will receive 5 g of this product daily in the form of 5 capsules in morning,noon, night for 3 months Sperm count. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Sperm analysis. Sperm motility. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Semen analysis. Sperm morphology. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Semen analysis. Semen volume. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Semen analysis. To determine the potential adverse events resulting from treatment process in patients in the intervention groups. Timepoint: during the study. Method of measurement: questionnaire-Observation-reportage. Vice chancellor for research,Tabriz University of Medical Sciences Approved 2015-09-14 Ethics committee of Tabriz University of Medical Sciences No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz Iran (Islamic Republic of)