search
Back to results

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

Primary Purpose

Infertility, Male

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bahman capsules
Placebo
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Semen parameters Male infertility oligospermia Traditional Medicine

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royan InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

extracted red Bahman and white bahman

Placebo

Arm Description

500 mg of extracted red Bahman and white bahman that is used once a day.

500 mg of placebo once time a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Testosterone
Evaluation the testosterone by ELISA level 3 months after intervention.
FSH
Evaluation the FSH level by ELISA 3 months after intervention.
LH
Evaluation the LH level by ELISA 3 months after intervention.
DNA defragmentation
Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.

Full Information

First Posted
November 9, 2016
Last Updated
April 26, 2017
Sponsor
Royan Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02998593
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Semen parameters Male infertility oligospermia Traditional Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
extracted red Bahman and white bahman
Arm Type
Experimental
Arm Description
500 mg of extracted red Bahman and white bahman that is used once a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg of placebo once time a day
Intervention Type
Drug
Intervention Name(s)
Bahman capsules
Intervention Description
Oral Use of Bahman capsules for 3 months by patients.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral use of placebo capsules by patients for 3 months.
Primary Outcome Measure Information:
Title
Semen analysis
Description
Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Testosterone
Description
Evaluation the testosterone by ELISA level 3 months after intervention.
Time Frame
3 months
Title
FSH
Description
Evaluation the FSH level by ELISA 3 months after intervention.
Time Frame
3 months
Title
LH
Description
Evaluation the LH level by ELISA 3 months after intervention.
Time Frame
3 months
Title
DNA defragmentation
Description
Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all idiopathic oligospermic patient in range of 20 to 45 years old 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
leara91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seyed Jalil Hosseini, PhD
Organizational Affiliation
Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoudreza Faghihi, MD,PhD
Organizational Affiliation
Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mina Movahed, MD,PhD
Organizational Affiliation
Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)2123562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name & Degree
Leila Arab, MD
Phone
(+98)2123562000
Ext
414
Email
Leara91@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://royaninstitute.org
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs