this double-blind clinical trial will be discussed about effectiveness of herbal capsules containing extracts of Tribulus terrestris, ginger and L-arginine on sexual desire. Based on personal complaints, 60 males 30 to 70 years old with decreased sexual desire and who do not underlying condition contain physical and mental disease that need treat ,randomly divided into, two groups receiving placebo capsules or herbal capsules twice-daily for 6 weeks. At the beginning and end of the study individual Visited and at the end of third week will be followed by telephone about the continuation of cooperation, possible side effects and exclusion criteria .The level of testosterone, anti-oxidants, Hullbert Index of Sexual Desire and libido (VAS) will be specified in the beginning and end of study and Changes will be calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122012438N14
Registration date:2016-01-09, 1394/10/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij research center of medicinal plants
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of capsule containinig Tribulus Terrestris, Zingiber Officinale extracts and L-arginine on libido of low libido men
Public title
The effect of capsule containinig Tribulus Terrestris, Zingiber Officinale extracts and L-arginine on male libido
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients between 30 and 70 years old with decreased sexual desire based on personal complaints
Exclusion criteria: internal medicine,use medicine affecting sexual performance
Addiction and smoking,alcohol
Psychiatric disease and family problems
Use herbal medicine that affect on sexual desire
Physical and Psychiatric disease wife, other
Sexual dysfunction
multi partner
Known sensitivity to medicinal herbal used in the study
Any psychological counseling during the study period
Age
From 30 years old to 70 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
ir.kaums.rec1394.93181122
Health conditions studied
1
Description of health condition studied
loss of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
Hullbert Index of Sexual Desire
Timepoint
Baseline and End-of-trial
Method of measurement
questionnaire
2
Description
Libido
Timepoint
Baseline and End-of-trial
Method of measurement
VAS
3
Description
TAC
Timepoint
Baseline and End-of-trial
Method of measurement
blood sample
4
Description
Testosterone
Timepoint
Baseline and End-of-trial
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:herbal capsule-two times a day for 6 weeks
Category
Treatment - Drugs
2
Description
control:placebo capsule-two times a day for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad Hospital in Kashan, Kashan
Full name of responsible person
Dr Mohsen Taghizadeh
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Km. 44 of Kashan - Delijan Rd, Mashhad-e- Ardehal Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
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 Kashan University of Medical Science
Proportion provided by this source
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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Medicine Kashan University Of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
00
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
00
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Mahnaz.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Km. 44 of Kashan, Delijan Rd, Mashhad e Ardehal Kashan
City
Kashan
Postal code
Phone
00
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)