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 : Recruiting
First Posted : December 20, 2016
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Male||Drug: Bahman capsules Drug: Placebo||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
Oral use of placebo capsules by patients for 3 months.
- Semen analysis [ Time Frame: 3 months ]Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.
- 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.
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
|Contact: Nasser Aghdami, MD,PhD||(+98)23562000 ext firstname.lastname@example.org|
|Contact: Leila Arab, MD||(+98)23562000 ext email@example.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: Nasser Aghdami, MD,PhD (+98)2123562000 ext 516 firstname.lastname@example.org|
|Contact: Leila Arab, MD (+98)2123562000 ext 414 Leara91@gmail.com|
|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|