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The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men

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ClinicalTrials.gov Identifier: NCT02998593
Recruitment Status : Unknown
Verified October 2016 by Royan Institute.
Recruitment status was:  Recruiting
First Posted : December 20, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Infertility, Male Drug: Bahman capsules Drug: Placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: extracted red Bahman and white bahman
500 mg of extracted red Bahman and white bahman that is used once a day.
Drug: Bahman capsules
Oral Use of Bahman capsules for 3 months by patients.

Placebo Comparator: Placebo
500 mg of placebo once time a day
Drug: Placebo
Oral use of placebo capsules by patients for 3 months.




Primary Outcome Measures :
  1. Semen analysis [ Time Frame: 3 months ]
    Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.


Secondary Outcome Measures :
  1. Testosterone [ Time Frame: 3 months ]
    Evaluation the testosterone by ELISA level 3 months after intervention.

  2. FSH [ Time Frame: 3 months ]
    Evaluation the FSH level by ELISA 3 months after intervention.

  3. LH [ Time Frame: 3 months ]
    Evaluation the LH level by ELISA 3 months after intervention.

  4. DNA defragmentation [ Time Frame: 3 months ]
    Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998593


Contacts
Contact: Nasser Aghdami, MD,PhD (+98)23562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)23562000 ext 414 leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)2123562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)2123562000 ext 414    Leara91@gmail.com   
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Seyed Jalil Hosseini, PhD Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Study Director: Mahmoudreza Faghihi, MD,PhD Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
Principal Investigator: Mina Movahed, MD,PhD Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02998593     History of Changes
Other Study ID Numbers: Royan-Emb-026
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Royan Institute:
Semen parameters Male infertility oligospermia Traditional Medicine

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female