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IRCT20100414003706N36 IRCT 2020-05-17 Tabriz University of Medical Sciences 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 2020-05-21 anticipated 50 Complete https://irct.ir/trial/45992 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated into intervention or control groups using stratified (two strata; with moderate depressive symptoms or with no or mild depressive symptoms) block randomization with block size of 4 and allocation ratio of 1: 1. Allocation sequence will be determined using a computerized program (randomizer). To conceal the allocation, we will use sequentially numbered identical drug containers, Blinding description: The safrotine, safrodide and placebo capsules will look quite similar, quite similar. Sequence allocation and preparation of drug packages will be performed by a non-involved person in sampling and data collection. The researcher, data collector, and analyzer will not be aware of the type of intervention received. 3 Sexual dysfunction. 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. Intervention 2: Control group: For 8 weeks, each day one oral placebo capsule (identical with saffrotine in terms of appearance, smell and taste) and a 50 mg vitamin E capsule (identical with saffradid in terms of appearance, smell and taste); produced by Green Plants of life Company. Yes - There is a plan to make this available What will be shared: All deidentified IPD can be shared. When: Starting just after publication To whom: Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript. Conditions: The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief editor of the journals for checking. Where to obtain: Refer to the email address. (alizades@tbzmed.ac.ir) How to obtain: Requests will be sent by email and data will be available within two weeks. Comments:
public Saeideh Izadi
Faculty of Nursing and Midwifery, South Shariati End
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3479 6770 saeideizadi485@gmail.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South Shariati
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 2699 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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) 15 years 49 years Female 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 F52.22 Female sexual arousal disorder Treatment - Drugs Treatment - Drugs 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. Control group: For 8 weeks, each day one oral placebo capsule (identical with saffrotine in terms of appearance, smell and taste) and a 50 mg vitamin E capsule (identical with saffradid in terms of appearance, smell and taste); produced by Green Plants of life Company. 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). 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). Tabriz University of Medical Sciences Approved 2020-05-04 Ethics committee of Tabriz University of Medical Sciences Third floor, Second centralbuilding, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)