Clinical trial NCT02998593: The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men
Official title: Effect of Red and White Bahman on Semen Parameters,Testosteron ,LH, FSH and Defragmentation of DNA . A Double Blind Randomised Clinical Trial (Phase 3)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility, Male
Keywords: Semen parameters Male infertility oligospermia Traditional Medicine
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2016-12-20
Enrollment: 200
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective double blind randomized controlled trial to investigate the effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation in idiopathic oligospermic men .Include patients will take the medicine and placebo in different two case and control groups for 3 month and semen parameters and other variants at the start and end of study.

Detailed description: This is a randomized, double blind; placebo-controlled clinical trial has been started from july 2016 and will continue to july 2016 in Royan institute. The eligible patients who fulfilled the study criteria will be included in the trial.

Study protocol and assays All the patients will have a complete history evaluation and physical examination by the attending urologist who is blinded to the study and enter the study according to inclusion criteria.. semen analysis and hormonal laboratory tests \[Testosterone, Luteinizing hormone (LH) Follicle stimulating hormone(FSH)\] will done in same lab at start of study and 3 month after. Intervention time is 3 month for each patient. semen analysis wil be done according to who laboratory manual for the examination and processing of human semen 5th edition and hormonal tests (LH,FSH,Testosterone) with Elisa method (with score of International Unit). DNA Defragmentation will evaluate with Sperm Chromatin Structure Assay(SCSA) method. semen parameters which will evaluate is the number of normal and abnormal shape sperms, velocity of sperms, volume and viscosity of semen at start and end of the study. medicine and placebo prescribe in 500mg capsules for 3month. red and white Bahman is an effective medicine in male infertility treatment In Iranian Traditional Medicine. at the end of study main aim of the study is evaluation effect of combination of Red and White Bahman retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic . Red Bahman and White bahman ,nutrition ,placebo, smoking and Testosterone,LH,FSH,Concentration,number,sha-pe,of sperm before and after the study is variables of study.

Eligibility criteria: Inclusion Criteria:

1. all idiopathic oligospermic patient in range of 20 to 45 years old
2. sperm count under 15 million /ml 3;No history of taking chemical or herbal medicine effective on sperm genesis in last 3 month( like Hormonal drug ,antidepressant ,anti hypertension,cimetidine, cyproteron, sulphasalazine, flutamide, spironolactone, estrogen,opium 4:No history of Varicocele and Obstructive disease 5:;No leukocytospermia

Exclusion Criteria:

Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent); 2. ; Increasing BMI \> 30 3. Leukocytospermia 4. varicocele

Primary outcomes:
measure: Semen analysis
timeFrame: 3 months
Secondary outcomes:
measure: Testosterone
timeFrame: 3 months
measure: FSH
timeFrame: 3 months
measure: LH
timeFrame: 3 months
measure: DNA defragmentation
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
name: Seyed Jalil Hosseini, PhD
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
name: Mahmoudreza Faghihi, MD,PhD
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
name: Mina Movahed, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: