The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men
NCT ID: NCT02998593
Last Updated: 2017-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2016-07-31
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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extracted red Bahman and white bahman
500 mg of extracted red Bahman and white bahman that is used once a day.
Bahman capsules
Oral Use of Bahman capsules for 3 months by patients.
Placebo
500 mg of placebo once time a day
Placebo
Oral use of placebo capsules by patients for 3 months.
Interventions
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Bahman capsules
Oral Use of Bahman capsules for 3 months by patients.
Placebo
Oral use of placebo capsules by patients for 3 months.
Eligibility Criteria
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Inclusion Criteria
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
20 Years
45 Years
MALE
No
Sponsors
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Royan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Hamid Gourabi, PhD
Role: STUDY_CHAIR
Head of Royan Institute
Seyed Jalil Hosseini, PhD
Role: STUDY_DIRECTOR
Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Mahmoudreza Faghihi, MD,PhD
Role: STUDY_DIRECTOR
Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
Mina Movahed, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
Locations
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Royan Institute
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Nasser Aghdami, MD,PhD
Role: primary
Leila Arab, MD
Role: backup
Related Links
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Related Info
Other Identifiers
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Royan-Emb-026
Identifier Type: -
Identifier Source: org_study_id