NCT02032251

Brief Summary

This study is a randomized, double blind, controlled clinical trials assess the efficacy of the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
Last Updated

January 9, 2014

Status Verified

October 1, 2009

Enrollment Period

9 months

First QC Date

January 8, 2014

Last Update Submit

January 8, 2014

Conditions

Infertility

Keywords

Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine

Outcome Measures

Primary Outcomes (1)

  • sperm DNA fragmentation

    Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.

    3 months

Secondary Outcomes (3)

  • male hormones

    3months

  • sperm count

    3 months

  • sperm motility

    3 months

Study Arms (2)

ginger

EXPERIMENTAL

The patients with infertility that underwent oral administration of ginger.

Drug: oral administration of ginger

Placebo

PLACEBO COMPARATOR

The patients with infertility that receive placebo.

Drug: Placebo

Interventions

oral administration of gingerDRUG

Oral administration of ginger in patients with infertility.

Also known as: Administration of herbal drug
ginger
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • men with idiopathic infertility or unexplained

You may not qualify if:

  • history of varicocele, genitourinary inflammation or infection
  • history of cigarette smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Ali DaliriHampa, MD

    Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

    STUDY DIRECTOR

  • Eyed Jalil Hosseini, MD

    Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

    STUDY DIRECTOR

  • Hani Department of Andrology, Reproductive Biomedicine Center, Roya, MSc

    Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

January 8, 2014

First Posted

January 9, 2014

Study Start

December 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

January 9, 2014

Record last verified: 2009-10

Locations

IR(1)