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IRCT20191207045632N1 IRCT 2021-07-04 Sabzevar University of Medical Sciences Investigating the effect of royal jelly on Sexual Dysfunction due to the use of selective serotonin reuptake inhibitors Investigating the effect of royal jelly on Post-SSRI Sexual Dysfunction (PSSD) due to the use of selective serotonin reuptake inhibitors 2021-06-20 anticipated 60 Complete https://irct.ir/trial/44060 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced (permuted) block randomization in this study people will be divided in 2 groups using block permutation. in this method A stands for who receives treatment and B stands for who's in control group. Considering the quadruple block, code 0 would be for AABB permutation, code 1 for ABAB, code 2 for ABBA, code 3 for BAAB, code 4 for BBAA and code 5 for BABA. then using Random numbers table one starting point will be chosen randomly. considering table's numbers layout, every number will be given it's own permutation for example if three random numbers be 2,0,1 treatment receiving layout in first 12 persons would be ABBAAABBABAB. one of envelopes will be chosen randomly when the patient comes and based on the given words the patient will be in treatment or control group. thus at last every 60 person's designation in 2 groups will be done using choosing numbers from table, Blinding description: This study is double blinded clinical trial in which each person in the study will be assigned codes "A" and "B" that only researcher knows about the groups and the participants and the physician are unaware of the groups. the drug and the placebo have exact shape, cover, color and weight and only researcher knows which one of them each patient is taking. 2-3 post SSRI sexual dysfunction. Intervention 1: Intervention group: Royal gel capsules which is made from freezing and grinding the Royal gel ( queen bee's discharges) in Sabzevar university of medical science's lab will be given once a day for 8 weeks. Intervention 2: Control group: placebo consist of farina with the exact same color, weight and cover to intervention group's drug will be prescribed for 8 weeks and one pill a day. Yes - There is a plan to make this available What will be shared: information about level of sexual dysfunction during different time of research and response to drug When: 6 month after publishment To whom: university research departments with related subjects and Pharmaceutical Companies Conditions: in case of requirement for information to produce drug or develop the reasearch Where to obtain: Fateme Shokoohy parastoo.shokuhi@yahoo.com Dr.Davood Mahdian mahdiand64@gmail.com How to obtain: mailing the given contacts and sending required information Comments:
public Fateme Shokoohy
No.131, 11th taleqani, sabzevar town
Sabzevar Iran (Islamic Republic of) 9617699117 +98 11 3334 9579 parastoo.shokuhi@yahoo.com Sabzevar University of Medical Sciences scientific Davood Mahdian
No.131, 11th taleqani Ave, Sabzevar
Sabzevar Iran (Islamic Republic of) 9617699117 +98 11 3334 9578 mahdiand64@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) patients with any psychological disease that need SSRI patients with sexual dysfunction after using SSRI patients aged between 20 to 45 20 years 45 years Both patients who do not use SSRI regularly patients who had sexual dysfunction history before using SSRI F32 Major depressive disorder, single episode Treatment - Drugs Placebo Intervention group: Royal gel capsules which is made from freezing and grinding the Royal gel ( queen bee's discharges) in Sabzevar university of medical science's lab will be given once a day for 8 weeks. Control group: placebo consist of farina with the exact same color, weight and cover to intervention group's drug will be prescribed for 8 weeks and one pill a day. Sexual function. Timepoint: at the beginning of the study ( before intervention), week 2, week 4, week 6 and week 8. Method of measurement: Arizona sexual experience scale (ASEX) and the changes in sexual functioning questionnaire (CSFQ). Sabzevar University of Medical Sciences Approved 2019-04-27 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Science building, Tohid shahr Blvd, Sabzevar Sabzevar Razavi Khorasan Iran (Islamic Republic of)