<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02998593</url>
  </required_header>
  <id_info>
    <org_study_id>Royan-Emb-026</org_study_id>
    <nct_id>NCT02998593</nct_id>
  </id_info>
  <brief_title>The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royan Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royan Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective double blind randomized controlled trial to investigate the&#xD;
      effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation&#xD;
      in idiopathic oligospermic men .Include patients will take the medicine and placebo in&#xD;
      different two case and control groups for 3 month and semen parameters and other variants at&#xD;
      the start and end of study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double blind; placebo-controlled clinical trial has been started from&#xD;
      july 2016 and will continue to july 2016 in Royan institute. The eligible patients who&#xD;
      fulfilled the study criteria will be included in the trial.&#xD;
&#xD;
      Study protocol and assays All the patients will have a complete history evaluation and&#xD;
      physical examination by the attending urologist who is blinded to the study and enter the&#xD;
      study according to inclusion criteria.. semen analysis and hormonal laboratory tests&#xD;
      [Testosterone, Luteinizing hormone (LH) Follicle stimulating hormone(FSH)] will done in same&#xD;
      lab at start of study and 3 month after. Intervention time is 3 month for each patient. semen&#xD;
      analysis wil be done according to who laboratory manual for the examination and processing of&#xD;
      human semen 5th edition and hormonal tests (LH,FSH,Testosterone) with Elisa method (with&#xD;
      score of International Unit). DNA Defragmentation will evaluate with Sperm Chromatin&#xD;
      Structure Assay(SCSA) method. semen parameters which will evaluate is the number of normal&#xD;
      and abnormal shape sperms, velocity of sperms, volume and viscosity of semen at start and end&#xD;
      of the study. medicine and placebo prescribe in 500mg capsules for 3month. red and white&#xD;
      Bahman is an effective medicine in male infertility treatment In Iranian Traditional&#xD;
      Medicine. at the end of study main aim of the study is evaluation effect of combination of&#xD;
      Red and White Bahman retrieved of Iranian Traditional Medicine on Semen Parameters in&#xD;
      Idiopathic Oligospermic . Red Bahman and White bahman ,nutrition ,placebo, smoking and&#xD;
      Testosterone,LH,FSH,Concentration,number,sha-pe,of sperm before and after the study is&#xD;
      variables of study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Semen analysis</measure>
    <time_frame>3 months</time_frame>
    <description>Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Testosterone</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation the testosterone by ELISA level 3 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FSH</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation the FSH level by ELISA 3 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LH</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation the LH level by ELISA 3 months after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DNA defragmentation</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Infertility, Male</condition>
  <arm_group>
    <arm_group_label>extracted red Bahman and white bahman</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 mg of extracted red Bahman and white bahman that is used once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>500 mg of placebo once time a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bahman capsules</intervention_name>
    <description>Oral Use of Bahman capsules for 3 months by patients.</description>
    <arm_group_label>extracted red Bahman and white bahman</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral use of placebo capsules by patients for 3 months.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. all idiopathic oligospermic patient in range of 20 to 45 years old&#xD;
&#xD;
          2. sperm count under 15 million /ml 3;No history of taking chemical or herbal medicine&#xD;
             effective on sperm genesis in last 3 month( like Hormonal drug ,antidepressant ,anti&#xD;
             hypertension,cimetidine, cyproteron, sulphasalazine, flutamide, spironolactone,&#xD;
             estrogen,opium 4:No history of Varicocele and Obstructive disease 5:;No&#xD;
             leukocytospermia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm&#xD;
        reducing and increasing agent); 2. ; Increasing BMI &gt; 30 3. Leukocytospermia 4. varicocele&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hamid Gourabi, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Royan Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seyed Jalil Hosseini, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mahmoudreza Faghihi, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mina Movahed, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nasser Aghdami, MD,PhD</last_name>
    <phone>(+98)23562000</phone>
    <phone_ext>516</phone_ext>
    <email>nasser.aghdami@royaninstitute.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leila Arab, MD</last_name>
    <phone>(+98)23562000</phone>
    <phone_ext>414</phone_ext>
    <email>leara91@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royan Institute</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nasser Aghdami, MD,PhD</last_name>
      <phone>(+98)2123562000</phone>
      <phone_ext>516</phone_ext>
      <email>nasser.aghdami@royaninstitute.org</email>
    </contact>
    <contact_backup>
      <last_name>Leila Arab, MD</last_name>
      <phone>(+98)2123562000</phone>
      <phone_ext>414</phone_ext>
      <email>Leara91@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://royaninstitute.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>April 26, 2017</last_update_submitted>
  <last_update_submitted_qc>April 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Semen parameters Male infertility oligospermia Traditional Medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998593
org study id: Royan-Emb-026
nct id: NCT02998593
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Semen analysis
time frame: 3 months
description: Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.
measure: Testosterone
time frame: 3 months
description: Evaluation the testosterone by ELISA level 3 months after intervention.
measure: FSH
time frame: 3 months
description: Evaluation the FSH level by ELISA 3 months after intervention.
measure: LH
time frame: 3 months
description: Evaluation the LH level by ELISA 3 months after intervention.
measure: DNA defragmentation
time frame: 3 months
description: Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.
arm group label: extracted red Bahman and white bahman
arm group type: Experimental
description: 500 mg of extracted red Bahman and white bahman that is used once a day.
arm group label: Placebo
arm group type: Placebo Comparator
description: 500 mg of placebo once time a day
intervention type: Drug
intervention name: Bahman capsules
description: Oral Use of Bahman capsules for 3 months by patients.
arm group label: extracted red Bahman and white bahman
intervention type: Drug
intervention name: Placebo
description: Oral use of placebo capsules by patients for 3 months.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Hamid Gourabi, PhD
role: Study Chair
affiliation: Head of Royan Institute
last name: Seyed Jalil Hosseini, PhD
role: Study Director
affiliation: Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
last name: Mahmoudreza Faghihi, MD,PhD
role: Study Director
affiliation: Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
last name: Mina Movahed, MD,PhD
role: Principal Investigator
affiliation: Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
last name: Nasser Aghdami, MD,PhD
phone: (+98)23562000
phone ext: 516
email: nasser.aghdami@royaninstitute.org
last name: Leila Arab, MD
phone: (+98)23562000
phone ext: 414
email: leara91@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Iran, Islamic Republic of
url: http://royaninstitute.org
description: Related Info
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Male
sharing ipd: No