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

Effect of addition of saffron to vitamin E on the sexual function in women of reproductive age with sexual dysfunction: a randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100414003706N36
Enrollment
50
Registered
2020-05-17
Start date
2020-05-21
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual dysfunction. Female sexual arousal disorder

Interventions

Intervention 1: Intervention group: For 8 weeks, each day one saffrotine capsule (15 mg saffron) and one saffradid capsule (15 mg saffron+ 50 mg vitamin E), produced by Green Plants of life Company. I
produced by Green Plants of life Company.

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 49 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeideh Izadi

Tabriz University of Medical Sciences

saeideizadi485@gmail.com+98 41 3479 6770

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026