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IRCT20210929052627N1 IRCT 2022-01-10 Mashhad University of Medical Sciences The effect of nettle capsules on sexual desire and satisfaction of postmenopausal women The effect of total nettle capsules on sexual desire and satisfaction of postmenopausal women aged 45-65 years 2022-01-21 anticipated 60 Complete https://irct.ir/trial/59942 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple Based on sealed envelopes The random sequence of the sample is done using random allocation software in two groups A and B. Allocation concealment will be using sealed envelopes. At the beginning of the registration, the entry of the eligible participants will be opened in one of the envelopes and the assigned group will be determined and they will be given capsule A or B based on the assigned group, Blinding description: The subjects, analysts, evaluators, and samplers will be unaware of the intervention and control groups. The capsules of the intervention group and the placebo group are named groups A and B by the pharmacist consultant, and until the end of the study and analysis, the subjects, researchers and analysts will be unaware of the type of capsules. 1 The effect of nettle capsule on sexual desire and satisfaction. Intervention 1: Intervention group: In the intervention group, after obtaining the inclusion criteria and before starting the intervention, first the Halbert sexual orientation and Larson sexual satisfaction questionnaires are filled out and after explaining the study objectives and how to use oral capsules, they are asked to Use nettle capsules containing 500 mg of active ingredient once a week. At the end of week 4, the women fill out the Halbert and Larson questionnaires again, and four weeks after treatment (end of week 8), the Halbert and Larson questionnaire will be completed again. Intervention 2: Control group: They are asked to use nettle extract capsules once a day for 4 weeks. The placebo capsule contains Oisel, which is an inert substance and has no systemic absorption. This capsule is exactly the same in appearance as the intervention. At the end of week 4, women will fill out the Halbert and Larson questionnaires again, and four weeks after treatment (at the end of the eighth week), the Halbert and Larson questionnaires will be filled out again. Yes - There is a plan to make this available What will be shared: In this study, after blinding patients' private information, all data files will be provided to researchers. When: 6Months after the results are published To whom: Researchers working in academic and scientific institutions, people working in industry Conditions: The use of information by individuals will be fully permitted subject to the names of the researchers. We are also excused from publishing patients' private information. Where to obtain: Azam Azarboun azarbouna982@mums.ac.ir ID Tele: a.azarboon How to obtain: My email will be texted and will be answered within one to two weeks. AzarbounA982@mums.ac.ir Comments:
public Azam Azarboun
School of Nursing and Midwifery, Ibn Sina St., Doctoral Crossroads, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 AzarbounA982@mums.ac.ir Mashhad University of Medical Sciences scientific Azam Azarboun
School of Nursing and Midwifery, Ibn Sina St., Doctoral Crossroads, Mashhad
mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 AzarbounA982@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) At least 12 months after the last menstrual period or follicle-stimulating hormone greater than 40IU Sexual satisfaction score less than 75 and depression score less than 21, anxiety score less than 20, stress score less than 26 of DASS-21 questionnaire Menopausal women 65-45 years old Single spouse Have at least once or twice a week of normal vaginal intercourse No chronic diseases (diabetes, hypertension, fat, etc.) Lack of hormone therapy or consumption of sex hormones during the 8 weeks before the study No smoking and alcohol No abnormal uterine bleeding or spotting Lack of frequent use of other phytoestrogen drugs (soy, red clover, fenugreek, five fingers, fennel) in the past month Do not take drugs that affect sexual function by the wife or spouse Absence of known medical and psychological illnesses affecting the sexual function of oneself or one's spouse Having conscious satisfaction Iranian nationality Resident of Mashhad No history of chemotherapy and pelvic or whole body radiotherapy No history of sexually transmitted diseases, mastectomy, chlorpuraphy 45 years 65 years Female Symptoms of drug allergy Taking any medication that affects sexual function during the study Not having sex once a week during the study Taking hormonal drugs or containing phytoestrogens during research Experience unfortunate or stressful events in the wife or her husband while studying Dissatisfaction with continued cooperation Do not take the drug for 3 consecutive times or 4 non-consecutive times F52 Sexual dysfunction, not caused by organic disorder or disease Sexual dysfunction covers the various ways in which an individual is unable to participate in a sexual relationship as he or she would wish. Sexual response is a psychosomatic process and both Treatment - Drugs Placebo Intervention group: In the intervention group, after obtaining the inclusion criteria and before starting the intervention, first the Halbert sexual orientation and Larson sexual satisfaction questionnaires are filled out and after explaining the study objectives and how to use oral capsules, they are asked to Use nettle capsules containing 500 mg of active ingredient once a week. At the end of week 4, the women fill out the Halbert and Larson questionnaires again, and four weeks after treatment (end of week 8), the Halbert and Larson questionnaire will be completed again. Control group: They are asked to use nettle extract capsules once a day for 4 weeks. The placebo capsule contains Oisel, which is an inert substance and has no systemic absorption. This capsule is exactly the same in appearance as the intervention. At the end of week 4, women will fill out the Halbert and Larson questionnaires again, and four weeks after treatment (at the end of the eighth week), the Halbert and Larson questionnaires will be filled out again. Sexual desire. Timepoint: Before the study, after the intervention, four weeks after the intervention. Method of measurement: Halbert Questionnaire (HISA)؛This questionnaire consists of 25 questions, which assess the level of sexual desire of the subject. Each item is scored on a Likert scale with 5 degrees. The score range is between 0-100. Higher scores indicate more sexual desire. Sexual satisfaction. Timepoint: Before the study, after the intervention, four weeks after the intervention. Method of measurement: Larson Questionnaire; The scale considered for the analysis according to the score obtained is between 125-25, so that a score less than 50 means sexual dissatisfaction, 75-51 low satisfaction, 76-100 average satisfaction and more Out of 100, it indicates high sexual satisfaction. In this study, people with a sexual satisfaction score of less than 75 are included in the study. Mashhad University of Medical Sciences Approved 2021-11-07 Ethics committee of Mashhad university of Medical Sciences School of Nursing and Midwifery,Ibn Sina St., Ph.D. Intersection,University St. Mashhad Razavi Khorasan Iran (Islamic Republic of)