Double Blind Randomized placebo Controlled Clinical trial to compare the effect of dietary regimen with and without Lobub (A complex drug) for treatment of male subfertility with cold temperament according to Iranian Traditional Medicine
Objective: Double blind randomized placebo controlled clinical trial to compare the effect of dietary regimen with and without Lobub (a complex drug) for treatment of male subfertility.
Method: The patients with male factor subfertility will be randomized by block randomization to two groups; one group diet and placebo and the other diet and Lobub. The medication will be prepared by pharmaceutics university of medical sciences. After history tacking and physical examination and signing written consent forms, questionnaires on functional ejaculation parameters will be completed. All of the patients will receive dietary advices. (Semen analysis before medication will be performed by andrology laboratory of infertility clinic. After 2 and 3 months semen analysis and questionnaire completion will be repeated and the results will be compared)
All experiments will be done in a center. (mother and child hospital infertility lab) TO avoid potential errors .all patients diet on the base of traditions medicine will be modified .
And by block randomization method , to the first group lobub and to the second group placebo (made by traditional medicine, Shiraz University of Medical Sciences) will be administered . At the end of study the number, motility and normal sperm formation and fertility and performance indicators erection in the two groups will be measured.
Inclusion criteria: All infertile men with body mass index less than 30, who have not dyspepsia and sinusitis, those who have not burning sensation during ejaculation and yellow semen (possibility of warm dystemperament)
Exclusion criteria: Not willing to continue medication, sensitivity to the drug and complications. Primary outcome measures: Sperm morphology, motility and count Secondary outcome measure: functional ejaculation criteria
In the intervention group: drug therapy (Lobub 5gr/day for 3 months).
In the Control group: placebo, 5 grams per day for three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508036541N8
Registration date:2016-01-01, 1394/10/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-01, 1394/10/11
Registrant information
Name
Bahia Namavar Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
namavarb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Shiraz University of Medical Sciences.
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double Blind Randomized placebo Controlled Clinical trial to compare the effect of dietary regimen with and without Lobub (A complex drug) for treatment of male subfertility with cold temperament according to Iranian Traditional Medicine
Public title
Comparing the effect of dietary regimen with and without Lobub (a complex drug) for treatment of male subfertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Subfertile men with BMI<30, who have not dyspepsia and sinusitis, those who have not burning sensation during ejaculation and yellow semen (possibility of warm dystemperament) without a documented standard medical treatment in the literature.
Exclusion criteria: Not willing to continue medication, sensitivity to the drug and complications
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, patients will receive placebo or drug in accordance with block randomization list. Neither the patients nor the researchers are not aware of each subject receive what intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of medical Sciences
Street address
Shiraz University of Medical Sciences،Zand Street، Shiraz، Iran
City
Shiraz
Postal code
Approval date
2015-06-27, 1394/04/06
Ethics committee reference number
IR.SUMS.REC.1394.56
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N 46
ICD-10 code description
Male Infertility
Primary outcomes
1
Description
Sperm morphology, motility and count
Timepoint
Before and 2, and 3 months after intervention
Method of measurement
By semen analysis using 2010 WHO criteria
Secondary outcomes
1
Description
Erectile function questionnaire
Timepoint
Before and 2, and 3 months after intervention
Method of measurement
Standard Questionnaire
Intervention groups
1
Description
Intervention group Drug therapy Lobub 5gr/day for 3 months
Category
Treatment - Drugs
2
Description
In the Control group، placebo to 5 grams per day for three months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother & child hospital
Full name of responsible person
Dr. Amir Mohamad Jaladat
Street address
Ghadir Mother & child hospital- Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyd Basir Hashemi
Street address
Shiraz University of Medical Sciences،Zand Street، Shiraz، Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Amir Mohamad Jaladat
Position
Assistant professor of Traditional Persian Medicine
Other areas of specialty/work
Street address
Shiraz University of Medical Science،Zand Street، Shiraz، Iran
City
Shiraz
Postal code
Phone
+98 71332279715
Fax
Email
drjaladat@gmail.com s.kharati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Bahia Namavar Jahromi
Position
Fellowship of infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Science،zand street ، Shiraz، Iran
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
namavarb@sums.ac.ir ؛ s.kharati@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara kharati
Position
Bachelor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences،Zand street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
s.kharati@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)