Infertility, MalePhase 3NCT02998593
The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men
A Phase 3 study testing Bahman capsules in people with Infertility, Male, run by Royan Institute at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Bahman capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- Jul 2016to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent); 2. ; Increasing BMI > 30 3. Leukocytospermia 4. varicocele
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, (+98)2123562000 ext. 516, nasser.aghdami@royaninstitute.org
Leila Arab, MD, (+98)2123562000 ext. 414, Leara91@gmail.com
About this study
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)
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.
Read the 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.
- Conditions
- Infertility, Male
- Being tested
- Bahman capsules, Placebo
- Keywords
- Semen parameters Male infertility oligospermia Traditional Medicine
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bahman capsulesDrug
Oral Use of Bahman capsules for 3 months by patients.
PlaceboDrug
Oral use of placebo capsules by patients for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| extracted red Bahman and white bahman | Experimental | 500 mg of extracted red Bahman and white bahman that is used once a day. Receives: Drug: Bahman capsules |
| Placebo | Placebo comparator | 500 mg of placebo once time a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen analysis
Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.
Measured: 3 months
Secondary outcomes (4)
Testosterone
Evaluation the testosterone by ELISA level 3 months after intervention.
Measured: 3 months
FSH
Evaluation the FSH level by ELISA 3 months after intervention.
Measured: 3 months
LH
Evaluation the LH level by ELISA 3 months after intervention.
Measured: 3 months
DNA defragmentation
Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteSeyed Jalil Hosseini, PhD, Study director, Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.Mahmoudreza Faghihi, MD,PhD, Study director, Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,IranMina Movahed, MD,PhD, Principal investigator, Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998593
- Sponsor's protocol ID
- Royan-Emb-026
- Status last verified
- Oct 2016
- First submitted
- 9 Nov 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02998593
- Acronym / sponsor ID
- Royan-Emb-026
- Conditions
- Infertility, Male
- Keywords
- Semen parameters Male infertility oligospermia Traditional Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extracted red Bahman and white bahman | Experimental | Drug: Bahman capsules500 mg of extracted red Bahman and white bahman that is used once a day. |
| Placebo | Placebo comparator | Drug: Placebo500 mg of placebo once time a day |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent); 2. ; Increasing BMI > 30 3. Leukocytospermia 4. varicocele
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bahman capsulesOral Use of Bahman capsules for 3 months by patients. | Drug | extracted red Bahman and white bahman |
| PlaceboOral use of placebo capsules by patients for 3 months. | Drug | Placebo |
Primary outcome
Semen analysis
Time frame: 3 months
Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.
4 secondary outcomes
Testosterone
Time frame: 3 months
FSH
Time frame: 3 months
LH
Time frame: 3 months
DNA defragmentation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Infertility, Male
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Seyed Jalil Hosseini, PhD study director
Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Mahmoudreza Faghihi, MD,PhD study director
Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bahman capsules in people with Infertility, Male, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD ((+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen analysis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.