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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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)

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 Summary:

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.


Sponsor: Royan Institute

Current Primary Outcome: Semen analysis [ Time Frame: 3 months ]

Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Testosterone [ Time Frame: 3 months ]
    Evaluation the testosterone by ELISA level 3 months after intervention.
  • FSH [ Time Frame: 3 months ]
    Evaluation the FSH level by ELISA 3 months after intervention.
  • LH [ Time Frame: 3 months ]
    Evaluation the LH level by ELISA 3 months after intervention.
  • DNA defragmentation [ Time Frame: 3 months ]
    Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.


Original Secondary Outcome: Same as current

Information By: Royan Institute

Dates:
Date Received: November 9, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: April 26, 2017
Last Verified: October 2016