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Study the effect of mixed herbals drug (citrus,citrolus vol,lan,carrot seed,zingber,onion,basil,cinamon) administration on male infertility: oligospermia

Protocol summary

Summary
In the last few years, a marked decrease in the quality of semen has been reported. Infertility is one of the major health problems in 10 to 15% of couples’ lives; from which approximately 50% of couple's infertility is due to Male factors. The aim of the present study was to evaluate an herbal mixed effects on spermatogenesis and the normal production of sperm .Researchers have reported that using antioxidants and vitamins A, B, C, E, flavonoids, Sulfur compounds, terpenoids and phenolic compounds in the daily diet can protect sperm. In this study we aimed to assess synergistic effect of these herbal compounds in male Infertility.700 mg capsule for 60 consequence days/daily will be advising, for 40 patients semen samples in 1th and 60 day after treatment will take, for andrology lab according WHO method. Other biochemical tests will be doing according the our research protocol and thesis for blood samples for measure LH,Testestrone,TAC,Glc and Cholesterol.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012071410278N1
Registration date: 2012-08-07, 1391/05/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-08-07, 1391/05/17
Registrant information
Name
Arash Khaki
Name of organization / entity
Tabriz Univrsity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
arashkhaki@yahoo.com
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of mixed herbals drug (citrus,citrolus vol,lan,carrot seed,zingber,onion,basil,cinamon) administration on male infertility: oligospermia
Public title
Study the effect of mixed herbal drug administration on male infertility: oligospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients suffering from oligo spermia are included. Exclusion criteria: any diseases
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of medical Sciences
Street address
Tabriz,Golgasht Ave,
City
Tabriz
Postal code
51386
Approval date
2012-05-28, 1391/03/08
Ethics committee reference number
9026

Health conditions studied

1

Description of health condition studied
Oligo spermia
ICD-10 code
N46
ICD-10 code description
Male infertility

Primary outcomes

1

Description
Sperm count
Timepoint
First day of research, 2th time for sampling is 60 days after treatment
Method of measurement
Semen analysis

Secondary outcomes

1

Description
Sperm motality,viability
Timepoint
1th time in first day of research, 2th time after 60 days of treatment
Method of measurement
Semen analysis

Intervention groups

1

Description
each capsul contains 700 mg of 8 herbals.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr.Khaki
Street address
Tabriz, south Artesh Ave
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Elahe Madarek
Street address
Tabriz, Artesh Ave, Alzahra hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Arash Khaki
Position
Associate Prof in Pathology-Member
Other areas of specialty/work
Street address
Tabriz,South Artesh Ave,Alzahra Hospital
City
Tabriz
Postal code
51386
Phone
+98 41 1554 1221
Fax
+98 41 1554 1221
Email
arashkhaki@yahoo.com
Web page address
http://wrhrc.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Arash Khaki
Position
Member/Pathologist
Other areas of specialty/work
Street address
Tabriz South Artesh Ave,Alzahra Hospital
City
Tabriz
Postal code
51386
Phone
+98 41 1554 1221
Fax
+98 41 1554 1221
Email
arashkhaki@yahoo.com
Web page address
http://wrhrc.tbzmed.ac.ir/?MID=21&Type=News&TypeID=1&id=10

Person responsible for updating data

Contact
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Arash Khaki
Position
member/Pathologist
Other areas of specialty/work
Street address
Tabriz,S Artesh Ave,Alzahra Hospital
City
Tabriz
Postal code
51386
Phone
+98 41 1554 1221
Fax
+98 41 1554 1221
Email
arashkhaki@yahoo.com
Web page address
http://wrhrc.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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