Effect of addition of saffron to vitamin E on the sexual function in women of reproductive age

Phase 3

Recruiting

Conditions: Sexual dysfunction.
Female sexual arousal disorder
F52.22

Registration Number: IRCT20100414003706N36

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Literacy (to be able to fill out the questionnaires)
Married women aged 15 to 49 years
Sexual dysfunction (FSFI score of less than 28)
Sexually active
No sleep disorder (score 5 or less in Pittsburgh Sleep Quality Index)

Exclusion Criteria

Drug and alcohol addiction
Known sensitivity to saffron
Pregnancy
The first six months after delivery in lactating women
Severe depression or any other known psychological disorder
Occurrence of any serious stressors (such as separation of parents, death of a first-degree relative) in the last 3 months
Underlying diseases (heart, digestive, respiratory, epilepsy, hypertension, diabetes) according to self report
Regular use of any drugs affecting one's sexual response (including anti hypertensive drugs, thiazide diuretics, antidepressants, antihistamines, barbiturates, narcotics, diazepines, amphetamines, cocaine, herbal remedies)
Menopause
Daily consumption of saffron
Daily intake of vitamin E supplements
Participation in another trial
Obvious sexual dysfunction in husband (according to woman report)
No use of an effective contraceptive method
Willing to become pregnant in near future

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual function Score. Timepoint: At baseline, 4 and 8 weeks of intervention and 4 weeks after intervention. Method of measurement: Female sexual function questionnaire (FSFI).

Secondary Outcome Measures

Name	Time	Method
Anxiety. Timepoint: At baseline, 4 and 8 weeks of intervention and 4 weeks after intervention. Method of measurement: Depression, Anxiety and Stress Scale (DASS-21).;Depression. Timepoint: At baseline, 4 and 8 weeks of intervention and 4 weeks after intervention. Method of measurement: Depression, Anxiety and Stress Scale (DASS-21).;Stress. Timepoint: At baseline, 4 and 8 weeks of intervention and 4 weeks after intervention. Method of measurement: Depression, Anxiety and Stress Scale (DASS-21).