NCT01895816

Brief Summary

The purpose of this study is to determine whether the effect of mixed herbals drug (citrus, citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male infertility: oligospermia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

Same day

First QC Date

September 12, 2012

Last Update Submit

July 11, 2013

Conditions

Male Infertility

Keywords

male infertility,oligo spermia

Outcome Measures

Primary Outcomes (1)

  • Sperm count variation

    Semen analysis according WHO methods

    First day of research, 2th time for sampling is 180 days after treatment

Secondary Outcomes (2)

  • Sperm motility

    1th time in first day of research, 2th time after 180 days of treatment

  • Sperm Viability

    1th time in first day of research, 2th time after 180 days of treatment

Other Outcomes (2)

  • Testosterone levels

    1th time in first day of research, 2th time after 180 days of treatment

  • Serum Total antioxidant levels

    1th time in first day of research, 2th time after 180 days of treatment

Study Arms (1)

fertility coated tablet

EXPERIMENTAL

700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days

Dietary Supplement: coated tablet

Interventions

coated tabletDIETARY_SUPPLEMENT

this supplement contains 700 mg of 8 natural herbals: Citrus \& ZINGIBER OFFICINALE \& Onion \& Ocimum basilicum \& Cinnamomum zelanicum \& Citrullus lanatus \& Citrullus vulgaris \& Daucus carota

Also known as: Dietry supplement
fertility coated tablet

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all patients suffering from oligospermia are included

You may not qualify if:

  • any diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran

Tabriz, Azarbyjan, 51388, Iran

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Arash Khaki, PhD

    Women Reproductive Health Research Center,Tabriz University of medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor. Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Study Record Dates

First Submitted

September 12, 2012

First Posted

July 11, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

IR(1)