This study is a double blind clinical trial with placebo control groups that is conducted to determine the effect of saffron on female sexual function in reproductive age. The study population consisted of 80 women 39-18 years old in the health and medical centers which are covered by Tehran University of Medical Sciences. Among of them persons who have the inclusion criteria would have to be selected as sample. Inclusion criteria for the study included marital status, age being 39-18 years, not pregnant, not breastfeeding, minimal literacy, lack of erectile dysfunction in wife .Exclusion criteria included lack of desire to continue taking the drug, the occurrence of pregnancy During the study, adverse stressful life events (death of a relative). They then completed a questionnaire of Female sexual function, in the presence of sexual dysfunction will be included in the study and randomly assigned to undergoing the experimental groups, or controlled and receive capsule of Saffron (15 mg twice daily) or placebo for a period of 8weeks . At the end of the week 4 and after the intervention (end of week 8), sexual function will be assessed using the same questionnaire again. If these results prove the effectiveness of saffron in treating impotence, it can be used to treat female sexual function problems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206265912N5
Registration date:2013-10-13, 1392/07/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-13, 1392/07/21
Registrant information
Name
Mandana Mir Mohammad Ali Ei
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmohammad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research/ Tehran University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of saffron(crocus sativus) on female sexual function in reproductive age
Public title
the effect of saffron(crocus sativus) on female sexual function in reproductive age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women age 18-39 years; Iranian; Being married; No pregnancy
Lack of breastfeeding; The ability of Reading and writing; Lack of diseases affecting sexual function in person or her spouse; Lack of using drugs influence sexual function in person or her spouse; Lack of sexual dysfunction in her spouse;Not be multi partner her spouse; Not used hormonal drugs in recent months; Not used drugs in the past 6 months; Lack of allergy to herbal medicine; Lack of participation in other similar studies.
Exclusion criteria: Lack of volunteers willing to continue taking drug; The occurrence of pregnancy during the study; Symptoms of allergy medication;
Stressful life event.
Age
From 18 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tehran University of Medical Science
Street address
Tehran University of Medical Science, Pur Sina street, Qods street,Keshavarz Bulvar, Tehran
City
Tehran
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
92-01-99021934-90181
Health conditions studied
1
Description of health condition studied
female sexual dysfunction
ICD-10 code
F52.8
ICD-10 code description
other sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Desire
Timepoint
Before intervention/ 4 week after intervention/8week after intervention
Method of measurement
Standardized questionnaire FSFI
2
Description
Excitement
Timepoint
Before intervention/ 4 week after intervention/ 8 week after intervention
Method of measurement
Standardized questionnaire FSFI
3
Description
Lubricaton
Timepoint
Before intervention/ 4 week after intervention/ 8 week after intervention
Method of measurement
Standardized questionnaire FSFI
4
Description
Orgasem
Timepoint
Before intervention/ 4 week after intervention/ 8 week after intervention
Method of measurement
Standardized questionnaire FSFI
5
Description
Sexual Satisfaction
Timepoint
Before intervention/ 4 week after intervention/ 8 week after intervention
Method of measurement
Standardized questionnaire FSFI
6
Description
Dysparonia
Timepoint
Before intervention/ 4 week after intervention/ 8 week after intervention
Method of measurement
Standardized questionnaire FSFI
Secondary outcomes
empty
Intervention groups
1
Description
Saffron Ex tract/ Oral Capsul 15mg/ Twice a day/ For 8 week
Category
Treatment - Drugs
2
Description
Placebo/ No Action/Oral Placebo Capsul/ Twice a day for 8 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers Of Arak University Of Medical Sciense