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IRCT20100503003860N36 IRCT 2018-12-09 Shahid Beheshti University of Medical Sciences Effect of Vitex Plant on Female Sexual Function Effect of Vitex Plant on Female Sexual Function 2018-12-22 anticipated 102 Complete https://irct.ir/trial/35242 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and description of each method: In the custody In randomization unit: Individual Randomization tool: Random number function, opaque and closed envelopes How to create random sequence: Generate random number function in Excel software, Blinding description: In order to blind the allocation, the pills will be divided into the opaque A and B packets and numbered by the anonymous researcher in the sampling. Participant, clinical caregiver, researcher, and outcome evaluator of the type of intervention will be unaware. 3 Sexual dysfunction. Intervention 1: Intervention group: Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant; manufactured by Gol Dara Co.; Iran; at 0, 4, 8,12 and 16 weeks. Intervention 2: Control group: Administration of placebo tablet containing starch 2.3-4.8 mg; manufactured by Shahid Beheshti Pharmaceutical Faculty; Tehran; Iran; at 0, 4, 8,12 and 16 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Thereport plan is still unknown
public Giti ozgoli
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart HospitaŁ…
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2512 gozgoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Giti Ozgoli
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospital
Tehran Iran (Islamic Republic of) 1985717443 +98 218865536671 g.ozgoli@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Fertile women 15-44 years who referred for Pap smear Healthy in gynecological and physical examinations Seeking treatment for the improvement and enhancement of sexual function 15 years 44 years Female single Pregnant and lactating Illiterate / cannot read and write Having a specific illness (thyroid problems, diabetes, psychiatric disorders, hyper-prolactonemia, liver problems, etc.) Stressful event in the last 6 months (death or disease of immediate family member, a major change in lifestyle) of any of the couples Mental problems (illness under the supervision or treatment of a physician) in each of the couples according to the woman's statement Treated for any sexual problems in each of the couples according to the woman's statement Alcohol or drug addiction in each of the couples according to the woman's statement Women whose husbands are unable to have normal sex (e.g., erectile dysfunction or premature ejaculation) Any illness in women, including abnormal bleeding, cervicitis and vaginitis without premenstrual tension and premenstrual syndrome. Taking vitamin supplements or hormonal pills like contraceptives F52.0 Hypoactive sexual desire disorder Treatment - Drugs Treatment - Drugs Intervention group: Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant; manufactured by Gol Dara Co.; Iran; at 0, 4, 8,12 and 16 weeks Control group: Administration of placebo tablet containing starch 2.3-4.8 mg; manufactured by Shahid Beheshti Pharmaceutical Faculty; Tehran; Iran; at 0, 4, 8,12 and 16 weeks Sexual function. Timepoint: Before the intervention, 4,812 and 16 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire. Sexual desire score. Timepoint: Before the intervention, 4, 8,12 and 16 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire. Sexual Arousal Score. Timepoint: Before the intervention, 4, 8,12 and 16 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire. Orgasm Score. Timepoint: Before the intervention, 4, 8,12 and 16 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire. Coitus of Pain Score. Timepoint: Before the intervention, 4, 8,12 and 16 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire. Sexual Satisfaction Score. Timepoint: Before the intervention, 4, 8,12 and 16 weeks after the intervention. Method of measurement: Female Sexual Function Index questionnaire. Shahid Beheshti University of Medical Sciences Approved 2018-11-05 Ethics Committee of Shahid Beheshti University of Medical Sciences Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)