NCT02998593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

November 9, 2016

Last Update Submit

April 26, 2017

Conditions

Infertility, Male

Keywords

Semen parameters Male infertility oligospermia Traditional Medicine

Outcome Measures

Primary Outcomes (1)

  • Semen analysis

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

    3 months

Secondary Outcomes (4)

  • Testosterone

    3 months

  • FSH

    3 months

  • LH

    3 months

  • DNA defragmentation

    3 months

Study Arms (2)

extracted red Bahman and white bahman

EXPERIMENTAL

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

Drug: Bahman capsules

Placebo

PLACEBO COMPARATOR

500 mg of placebo once time a day

Drug: Placebo

Interventions

Bahman capsulesDRUG

Oral Use of Bahman capsules for 3 months by patients.

extracted red Bahman and white bahman
PlaceboDRUG

Oral use of placebo capsules by patients for 3 months.

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent); 2. ; Increasing BMI \> 30 3. Leukocytospermia 4. varicocele

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

RECRUITING

Related Links

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

  • Mina Movahed, MD,PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aghdami, MD,PhD

CONTACT

(+98)23562000nasser.aghdami@royaninstitute.org

Leila Arab, MD

CONTACT

(+98)23562000leara91@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

December 20, 2016

Study Start

July 1, 2016

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

April 28, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)