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IRCT20221017056213N1 IRCT 2022-12-04 Ghoum University of Medical Sciences Evaluation of the effect of oral product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age Evaluation of the effect of oral traditional Persian medicine product of silk (Bombyx mori L. Cocoon), on sexual dysfunction and Quality of Life in women of reproductive age, compare with placebo. a triple-blind randomized clinical trial 2022-11-22 anticipated 74 Complete https://irct.ir/trial/66360 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website, Blinding description: In this study, the patient, the researcher (project manager (doctor)) and the statistical consultant will not know about the syrup content and they will be blinded. Only the traditional medicine pharmacist who is responsible for the preparation of Iranian traditional medicine syrup and placebo syrup will know about the content of medicinal syrups. People who meet the inclusion criteria, if they want to participate in the study, after obtaining written informed consent, they will be given the traditional Iranian medicine syrup and placebo, which are in the same packaging and completely similar in terms of appearance, color and aroma. They receive a random face. A special code will be considered for each syrup and will be recorded on the syrup label. Only the pharmacist consultant will know about the drug codes. Medicines will be provided to the doctor and plan administrator and the patient. The code of each syrup specific to each patient will be entered in the patient's file and checklist by the administrator. At the end of the study, the information and checklist form of the patients will be provided to the statistics consultant for statistical analysis, and after the data analysis, the code of syrups will be provided to the administrator and statistics consultant for the final analysis by the pharmaceutical expert. 3 sexual dysfunction. Intervention 1: Intervention group: Patients will be given traditional Persian medicine products containing silk. Silk syrup is taken three times a day for 3 weeks and 10 cc each time. Intervention 2: Control group: Patients will be given a placebo product. Placebo syrup is taken 10 cc three times a day for 3 weeks. Yes - There is a plan to make this available What will be shared: Data will be sent by researchers upon request. All potential data can be shared after de-identifying individuals. When: After printing the results of the study To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: The data will be used only for use in published research articles and will not be made available to the public in any other way. Where to obtain: To receive the desired documents and data, please refer to the Faculty of Traditional Medicine of Qom University of Medical Sciences. How to obtain: The data will be accessible from the time of announcing the request to the responsible person and proving the scientific documents of the applicant that they are working researchers at the university, as well as reviewing the relevant study and research. Comments:
public fatemeh jahani
Faculty of Traditional Persian Medicine of Qom University of Medical Sciences, corner of Alley 44, 15 Khordad Blvd
Qom Iran (Islamic Republic of) 3714848350 00982537764073-4 fatima.jahani1370@gmail.com Ghoum University of Medical Sciences scientific Dr. fatemeh nojavan
Corner of Alley No.44, Faculty of Persian Traditional Medicine of Qom University of Medical Sciences, 15 Khordad Blvd
Qom Iran (Islamic Republic of) 3714848350 +98 25 37764073-4 fnojavan@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) Women aged 18-50 years The woman being married and her husband being monogamous FSFI women's sexual function index score<28 in the initial evaluation Ability to read, understand and complete the questionnaire People with BMI less than 30 Having informed consent to enter the study 18 years 50 years Female pregnancy and breastfeeding delaying menstruation for 2 months or more significant clinical findings in physical examination, screening tests or other findings that prevent safe participation in the study, including the presence of any organic, anatomical disease (such as malformation of the anatomy of the external genitalia, spinal cord injuries or related surgery), hormonal in the study group such as diabetes, cerebrovascular disease, liver and kidney function damage, heart disease, hypothyroidism, cancers in history and medical history of psychiatric diseases that are under drug treatment. receiving psychotherapy or other treatments for sexual dysfunction using tobacco, alcohol, drug abuse using any chemical and herbal medicine known to affect libido being participate in another clinical trial study major changes in recent relationships, ongoing or unforeseeable disorder or disturbance that is not related to his sexual dysfunction. F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Placebo Intervention group: Patients will be given traditional Persian medicine products containing silk. Silk syrup is taken three times a day for 3 weeks and 10 cc each time. Control group: Patients will be given a placebo product. Placebo syrup is taken 10 cc three times a day for 3 weeks. Sexual dysfunction. Timepoint: The beginning of the study, the end of the fourth week from the beginning of the intervention, one month after the end of the intervention. Method of measurement: female sexual function index Questionnaire. Quality of Life. Timepoint: The beginning and end of the study. Method of measurement: Quality of life questionnaire with 36 questions. Ghoum University of Medical Sciences Approved 2022-07-04 Research Ethics Committees of Qom University of Medical Sciences No. 83, Shahid Lotfi Niaser, Shahid Lotfi Niaser, Safashehr St., No. 83 Qom Ghoum Iran (Islamic Republic of)