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IRCT20190528043736N1 IRCT 2019-06-12 Assistant Professor of North Khorasan University of Medical Sciences effect of vitagnus on sexual function of Women 50 to 70 years old - The effect of vitagnus on sexual function of Women 50 to 70 years old Referring to the Retirement center of North Khorasan province 2019-06-10 anticipated 56 Complete https://irct.ir/trial/39838 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: -, Randomization description: Those who have the conditions for entry into the study are given the necessary explanations for the study. A written consent form is signed by the patient and his wife and this way, people enter the study. At first, a demographic and clinical data form is made by the researcher and sexual function of women is completed in the interview. Then, people are classified according to age in four groups: 55-50, 60-55, 65-60 and 65-70 years old. Individuals are assigned code, and the groups are separated and separated by each other, using the lottery of the intervention group and the placebo. People in both groups are homogeneous in terms of age, Blinding description: After the negotiation and conclusion of the contract with the pharmaceutical company Poursina Drosa Vitagnus, along with placebo, the company will supply the research unit. Both the vials and the placebo drops contain the same visual appearance, and will be inscribed only on the glass of the letters A and B. N/A Sexual dysfunction. Intervention 1: "Intervention group": Intervention group: It is recommended to the research unit that at the beginning of the morning, use 40 drops of vitagnus with a cold drink for 2 months in the morning. The research unit is trained every two weeks and at the time of being in the center, the amount of drops consumed before the next visit is required and thus, people in terms of how the drops are consumed and how much they are consumed By handing the empty glass to the researcher, the drug is examined. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed. Intervention 2: "Control group": It is recommended to the research unit that at the beginning of the morning, use placebo with a cold drink for 2 months in the morning. The research unit is trained every two weeks and at the time of being in the center, the amount of drops consumed before the next visit is required and thus, people in terms of how the drops are consumed and how much they are consumed By handing the empty glass to the researcher, the drug is examined. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -
public Zohre Abasi
N14,Khoram Ave, Molla Sadra Blvd
Bojnourd Iran (Islamic Republic of) 9415917533 +98 58 3621 6366 r.amini.gh1363@gmail.com Bojnourd University of Medical Sciences scientific Zohre Abasi
N14,Khoram Ave, Molla Sadra Blvd
Bojnourd Iran (Islamic Republic of) 9415917533 +98 58 3621 6366 r.amini.gh1363@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) 50-70 year-old women No known psychological illness Lack of emotional stress in the past six months (such as the death of close relatives) In spite of being a spouse and living together with a spouse Absent susceptibility to spices and essential oils Lack of alcohol Not using relaxation methods Non-use of hormonal, herbal and nerve drugs Non-participation in similar research Absence of a variety of cancers at the time of research Failure to have breast and genital cancer in the past (endometrium, cervix, ovary) Not getting bleeding or spotting Absence of sexually transmitted malformations 50 years 70 years Female Do not use drop for one week People whose sexual performance is above 23 Observe spotting or bleeding during research Use of estrogenic hormone or other herbal drugs of phytoestrogens affect the hormonal Occurrence of adverse event during research Sensitization F52.8 Other sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Placebo "Intervention group": Intervention group: It is recommended to the research unit that at the beginning of the morning, use 40 drops of vitagnus with a cold drink for 2 months in the morning. The research unit is trained every two weeks and at the time of being in the center, the amount of drops consumed before the next visit is required and thus, people in terms of how the drops are consumed and how much they are consumed By handing the empty glass to the researcher, the drug is examined. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed. "Control group": It is recommended to the research unit that at the beginning of the morning, use placebo with a cold drink for 2 months in the morning. The research unit is trained every two weeks and at the time of being in the center, the amount of drops consumed before the next visit is required and thus, people in terms of how the drops are consumed and how much they are consumed By handing the empty glass to the researcher, the drug is examined. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed. Sexual function. Timepoint: Comparison of the total sexual function of the units before, 4 weeks, 6 weeks, and 8 weeks after taking Vitagnus drops. Method of measurement: Comparison of sexual function before and after taking Vitagnus drops is measured by Rosen's Sexual Function Questionnaire. Menopause symptoms. Timepoint: At the beginning of the study (before the study) 4 weeks, 6 weeks, 8 weeks. Method of measurement: Demographics and clinical demographic data form. Assistant Professor of North Khorasan University of Medical Sciences Approved 2019-05-19 IR.NKUMS.REC.1398.007 No14, Khoram Ave, Molla Sadra Blvd, Bojnourd town bojnourd North Khorasan Iran (Islamic Republic of)