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General information
40
43
4043
2016-02-04, 1394/11/15
2016-05-21, 1395/03/01
2016-0205-0421 00:00:00
Secondary outcomes
#1
Side effects
Side effects such as itching, etc.
Side effects such as itching, etc.
عوارض جانبی
عوارض جانبی مانند خارش و غیره
عوارض جانبی مانند خارش و غیره
Protocol summary
Study aim
The aim of this study is to evaluate the efficacy of Iranian herbal remedy on spermogram parameter in men with idiopathic infertility.
Design
This study is a clinical trial without a control group and placebo, in the form of before_after analysis.
Settings and conduct
The infertile patients were referred to the Persian medicine infertility clinics in Imam Khomeini Hospital Complex with idiopathic oligo-astheno-teratozoospermia according to inclusion and exclusion criteria intake drug dose.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Men 20-45 years; 2. infertility for at least one year; 3. oligo-astheno-teratozoospermia unexplained according to WHO. Exclusion criteria: 1. The history of intake of chemotherapy, corticosteroid, anticoagulation, testosterone, and antiandrogen; 2. The incidence of severe cases of oligospermia; 3. infections, genital anatomical abnormalities, chromosomal abnormalities, history of surgery on the genital tract, and exposure to toxins; 4. Alcohol or drug abuse; 5. systemic diseases.
Intervention groups
The therapeutic dose is 5 g from remedy BID for 3 months, and after 3 months samples tested and new spermogram be analyzed, and the results will be compared.
Main outcome variables
Improving sperm volume or concentration or sperm motility or normal morphology of sperm is important.
General information
Reason for update
Making minor changes in some parts after the end of the trial
Acronym
IRCT registration information
IRCT registration number:IRCT2015100624377N1
Registration date:2015-11-06, 1394/08/15
Registration timing:registered_while_recruiting
Last update:2023-02-14, 1401/11/25
Update count:2
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Somaye Mahroozade
Name of organization / entity
Iranian Traditional Medicine schoo, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1913
Email address
mahrouzs891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences, Iranian Traditional Medicine fac
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2016-02-04, 1394/11/15
Trial completion date
2016-05-21, 1395/03/01
Scientific title
The efficacy of one of the Iranian Traditional Remedy(lobub morakab) in spermogram parameter in Idiopathic Male Infertility in Imam Khomeyni hospital
Public title
The efficacy of one of the Iranian Traditional Remedy on spermogram in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men 20-45 years
Infertility for at least one year
Unexplained Oligo-astheno-teratozoospermia according to WHO criteria: Sperm concentrations below 20 million per milliliter; 5. Motile sperm less than 50%; 6. The normal morphology less than 30%
Exclusion criteria:
History of taking chemotherapy, Corticosteroid, Anticoagulation, Testosterone, Antiandrogen
The incidence of severe cases of oligospermia (sperm concentration less than one million per milliliter)
Infections, genital anatomical abnormalities, chromosomal abnormalities, history of surgery on the genital tract, exposure to toxins
Alcohol or drug abuse
Systemic diseases (cancer, thyroid disease, liver and gall bladder diseases, renal failure, etc.)
The reluctance of patients to continue
Make any side effects from medication
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
43
Actual sample size reached:
43
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
The ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
IR.TUMS.REC.1394.847
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Diseases of male genital organs,Male infertility,
Primary outcomes
1
Description
Semen volume
Timepoint
At the begining of the trial, 3 months after end of the drug
Method of measurement
Semen analysis
2
Description
Sperm count
Timepoint
At the begining of the trial, 3 months after end of the drug
Method of measurement
Sperm analysis
3
Description
Sperm motility
Timepoint
At the begining of the trial, 3months after end of the drug
Method of measurement
Semen analysis
4
Description
Normal morphology
Timepoint
At the begining of the trial, 3months after end of the dru
Method of measurement
Semen analysis
Secondary outcomes
1
Description
Fertility
Timepoint
After treatment
Method of measurement
Partner pregnancy
2
Description
Side effects such as itching, etc.
Timepoint
During the intervention
Method of measurement
Patient report
Intervention groups
1
Description
Remedy recommended 5 g, twice a day with milk for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Somaye Mahroozade
Street address
Imam Khomeini hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Tehran University of Medical
Street address
Tehran university of Medical Sciense, Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
stat@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
School of Persian Medicine, Iran University of Medical Sciences
Full name of responsible person
Somaye Mahroozade
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, Iran University of Medical Sciences, No. 847, Vahdat Eslami ST.
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Fax
Email
dr.mahroozade@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Faculty of Tehran University of Medical Sciences