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
Objective: The aim of this study is to compare the efficacy of Traditional Iranian Medicine product based on Withania somnifera with pentoxifylline on sperm parameters in the idiopathic infertile married men. Design: This study is a triple blind controlled randomized Clinical trial. Setting and conduct: The 100 idiopathic infertile married men referring to Urology Clinic of Imam Reza Hospital with Infertility complaint and abnormality in count , motility and morphology of sperm analysis after confirming the urologist , containing inclusion/ exclusion criteria and patients satisfaction will enter the study. Inclusion criteria: Men 18-45 years؛ infertility for at least one year ؛unexplained oligo-astheno-teratozoospermia according to WHO criteria؛ absence of systemic diseases. Exclusion criteria: Smoking or alcohol or drug abuse؛ intaking any other chemical drugs during the study. Patients were randomly divided into two groups of 50 men(Withania somnifera group and Pentoxifylline group). For all patients at first sperm analysis will be done. Interventions: In Withania somnifera receiving group, patients will receive 5 g of this product daily in the form of 5 capsules for 3 months. In pentoxifylline receiving group, patients will receive 800mg of pentoxifylline granules with placebo powder in the form of 5 capsules daily for 3 months. After 3 months, sperm analysis will be again tested for two groups. Main outcome of this study is improvement in count, motility, morphology of sperm and semen volume.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092224135N1
Registration date:2016-01-28, 1394/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-28, 1394/11/08
Registrant information
Name
Ramin Nasimi doost Azgomi
Name of organization / entity
School of Traditional Medicine, Tabriz University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 9529
Email address
nasimir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-01-07, 1394/10/17
Expected recruitment end date
2016-09-07, 1395/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The efficacy of Withania somnifera on spermogram in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2015-09-14, 1394/06/23
Ethics committee reference number
TBZMED.REC.1394.529
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N46
ICD-10 code description
Diseases of male genital organs,Male infertility
Primary outcomes
1
Description
Sperm count
Timepoint
At the begining of the trial,90 days after the intervention
Method of measurement
Sperm analysis
2
Description
Sperm motility
Timepoint
At the begining of the trial,90 days after the intervention
Method of measurement
Semen analysis
3
Description
sperm morphology
Timepoint
At the begining of the trial,90 days after the intervention
Method of measurement
Semen analysis
4
Description
Semen volume
Timepoint
At the begining of the trial,90 days after the intervention
Method of measurement
Semen analysis
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospita, Tabriz University of Medical Sciences