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IRCT20210809052118N1 IRCT 2023-09-13 Shahid Beheshti University of Medical Sciences Effect of wet-cupping in treatment oligomenorrhea Pcos Effects of wet-cupping on calf muscles on improving amenorrhea and oligomenorrhea in patients with polycystic ovary syndrome (PCOs) 2023-11-21 anticipated 92 Complete https://irct.ir/trial/70117 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done in a non-random, easy way (available sample) and the classification of samples to be assigned to treatment is done in a Block randomization. In other words, people are randomly assigned to the treatment and control groups with equal numbers. The randomization unit is considered individual. RAS statistical software was used as a block randomization tool. 3 Polycystic Ovarian Syndrom. Intervention 1: Intervention group: Performing cupping of both legs once and on the 26th day of menstrual cycle- At first, the patient will be given the necessary advice about observing the necessary pre-cupping, such as food precautions. The patient sits on a chair next to the bed, the position of the leg cupping that the posterior-lateral part of the leg and the leg is equal to one foot of the hand above the outer ankle, with the cup, connected to the suction cup. The suction takes a few seconds and 30 times. Repeated cupping before cupping causes partial anesthesia and reduces the amount of pain caused by razor. Then، by observing the sterile tips with a bistorial blade No. 11 along the skin lines (almost oblique)، about 10 to 15 subtle superficial incisions are made on the epidermis and dermis surface. The cupping cup is placed again in the area and with three re-suction in it, excess blood is removed. At the end the area is bandaged after sterilization and recommendations are given for care. Intervention 2: Control group: Two groups receive 500 mg of metformin twice daily for three months. Yes - There is a plan to make this available What will be shared: The main result and some specific goals are published. Including: the number of menstrual cycles as The main result of the study and the effect of some specific goals such as (increasing the length of the bleeding period - improving the Quality of Life - bleeding in the next month). Confidentiality of information is maintained. Personal information is not published. Only information related to primary and secondary outcomes will be used and shared for analysis. When: 6 months after the publication of the article, the data will be published. To whom: Students and professors of universities of medical sciences and scientific institutions affiliated to universities and the Ministry of Health and Medical Education Conditions: The reasons for using the data it is necessary to obtain the source for the purpose of use the request and signature of the responsible official of the requesting institution Where to obtain: The scientific officer of the project- Correspondence to the declared e-mail tansaz_mojgan@yahoo.com How to obtain: Sending a written request with the signature of the official of the requesting institution to the e-mail address of the scientific officer of the project - confirmation of the Requirements to be met (obligation to mention the source) - checking the request and sending the data within a maximum of one month Comments:
public Mojgan Tansaz
No. 8, Shams Alley, in front of Tovanir,Vali Asr St., Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 tansaz_mojgan@yahoo.com Shahid Beheshti University of Medical Sciences scientific Shahrzad Zadeh Modares
Boroujerdi St., Shishegar Khaneh St., Fadaiyan Eslam St., Shoosh Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5631 4935 mahdiyeh_hospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with polycystic ovarian- age between 18 and 35 with menstrual disorder-who have menstrual cycles of at least 60 days in the last year. 18 years 35 years Female Patients using metformin or every hormonal drugs, including herbal and phytoestrogens, in the last three months Positive BHCG titer or lactating women People with coagulation disorders and anemia E28.0 Polycystic Ovarian Syndrom Treatment - Other Treatment - Drugs Intervention group: Performing cupping of both legs once and on the 26th day of menstrual cycle- At first, the patient will be given the necessary advice about observing the necessary pre-cupping, such as food precautions. The patient sits on a chair next to the bed, the position of the leg cupping that the posterior-lateral part of the leg and the leg is equal to one foot of the hand above the outer ankle, with the cup, connected to the suction cup. The suction takes a few seconds and 30 times. Repeated cupping before cupping causes partial anesthesia and reduces the amount of pain caused by razor. Then، by observing the sterile tips with a bistorial blade No. 11 along the skin lines (almost oblique)، about 10 to 15 subtle superficial incisions are made on the epidermis and dermis surface. The cupping cup is placed again in the area and with three re-suction in it, excess blood is removed. At the end the area is bandaged after sterilization and recommendations are given for care. Control group: Two groups receive 500 mg of metformin twice daily for three months. Frequency of menstrual cycle. Timepoint: First day and weeks 2, 4, 6, 8, 10, 12. Method of measurement: Asking the patient. Length of bleeding period. Timepoint: The first day and weeks 2، 4، 6، 8،10،12. Method of measurement: Ask the patient based on the number of days of bleeding. The amount of excess hair(hirsutism). Timepoint: The first day and weeks 4، 8، 12. Method of measurement: the Freeman Galloway chart. Quality of life of patients with polycystic ovary syndrome. Timepoint: The first day and weeks 4، 8، 12. Method of measurement: PCOSQ-50 Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-04-30 The specialized committee of ethics in biomedical research Shahid Beheshti University of Medical Sciences, No.2, Aarabi St., Daneshjoo Blvd., Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)