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

NCT ID: NCT02998593

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Infertility, Male

Keywords

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Semen parameters Male infertility oligospermia Traditional Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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extracted red Bahman and white bahman

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

Group Type EXPERIMENTAL

Bahman capsules

Intervention Type DRUG

Oral Use of Bahman capsules for 3 months by patients.

Placebo

500 mg of placebo once time a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral use of placebo capsules by patients for 3 months.

Interventions

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Bahman capsules

Oral Use of Bahman capsules for 3 months by patients.

Intervention Type DRUG

Placebo

Oral use of placebo capsules by patients for 3 months.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Seyed Jalil Hosseini, PhD

Role: STUDY_DIRECTOR

Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Mahmoudreza Faghihi, MD,PhD

Role: STUDY_DIRECTOR

Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran

Mina Movahed, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran

Locations

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Royan Institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Nasser Aghdami, MD,PhD

Role: CONTACT

Phone: (+98)23562000

Email: [email protected]

Leila Arab, MD

Role: CONTACT

Phone: (+98)23562000

Email: [email protected]

Facility Contacts

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Nasser Aghdami, MD,PhD

Role: primary

Leila Arab, MD

Role: backup

Related Links

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Other Identifiers

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Royan-Emb-026

Identifier Type: -

Identifier Source: org_study_id