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IRCT20200623047903N1 IRCT 2020-07-25 Gonabad University of Medical Sciences Effect of Leech Therapy and Dry cupping on Polycystic Ovary Syndrome Effect Of Leech therapy and Dry cupping with Contraceptives LD on Improvement of Menstrual Complaints in Women with Polycystic Ovary Syndrome 2020-07-25 anticipated 40 Complete https://irct.ir/trial/49170 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For sampling, first each qualified person is selected to enter the study and Then the samples will be placed in the available method based on 4 blocks and random allocation in each of the two intervention groups (intervention) A or (control) B. 4 blocks will be used for sampling(AABB, ABAB, BBAA, BABA, ABBA,BAAB), Blinding description: In this study each questionnaire will be marked with the letters A (intervention group) and B (control group). People who do statistical work and analysis of data are blind to each participant than the intervention provided in this way, the person does not know which questionnaire is related to which intervention.After explaining the research to the research units and obtaining informed written consent based on random allocation, they will be placed in two groups of intervention and control 4 blocks will be used for sampling(AABB, ABAB, BBAA, BABA, ABBA,BAAB). 3 Polycystic Ovary Syndrome. Intervention 1: Intervention group: In this group, Leech therapy and Dry cupping will be Performed once a week after the end of Menstrual Bleeding until the Start of the next Menstrual Period. At first Place Leeches from the Farthest Point to the Uterus,That is on the Ankle and then on the Waist an Uterus. Dry cupping with Leech Therapy will be Placed around the Navel and in the Back (around the Spine).This will be done for two months and people are followed up for 3 months. Intervention 2: Control group: This group is treated with Low dose (LD) pills with a combination of 0.03 mg of Ethinyl Estradiol and 0.15 mg of Levonorgestrel.It should be taken daily and at a specific time by the Person for 21 days from the Beginning of Menstruation and then the pill should be Stopped for 7 day and another pack should be started again.This will continue for two Consecutive Cycles. 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 Participants Information is Confidential
public Ainaz Khodaverdian
No. 79, Ranjbar Ave., West Taleghani
Bojnourd Iran (Islamic Republic of) 9414844363 +98 58 3222 3280 ainazkvn@gmail.com Gonabad University of Medical Sciences scientific Roghaieh Rahmany Beilandi
No. 79, Ranjbar Ave., West Taleghani
Bojnourd Iran (Islamic Republic of) 9414844363 +98 58 3222 3280 roghaiehrahmany@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) The Polycystic Ovaries based on the individual's satatement Having Written and oral consent to participate in the study Age range of 18 to 40 Having reading and writing Literacy Body mass index Between 18.5 to 24.9 Lack of drug use No having chronic physical disease They did not Receive any Treatment for Polycystic Ovaries for 6 Months ago Failing to use hormonal drugs during the study Do not Take Hormonal Medications During the Study Patients with Stable Medical Condition Not Pregnant No Breastfeeding People with Oligomenorrhea 18 years 40 years Female Individual Intolerance to Leeches or Dry Cupping or LD E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Drugs Intervention group: In this group, Leech therapy and Dry cupping will be Performed once a week after the end of Menstrual Bleeding until the Start of the next Menstrual Period. At first Place Leeches from the Farthest Point to the Uterus,That is on the Ankle and then on the Waist an Uterus. Dry cupping with Leech Therapy will be Placed around the Navel and in the Back (around the Spine).This will be done for two months and people are followed up for 3 months Control group: This group is treated with Low dose (LD) pills with a combination of 0.03 mg of Ethinyl Estradiol and 0.15 mg of Levonorgestrel.It should be taken daily and at a specific time by the Person for 21 days from the Beginning of Menstruation and then the pill should be Stopped for 7 day and another pack should be started again.This will continue for two Consecutive Cycles The Duration of the Menstrual cycle. Timepoint: Before the Intervention, 1 Month, 2 and 3 Months after the Intervention. Method of measurement: A Researcher-made Questionnaire and Calendar. Menstrual Bleeding Volume. Timepoint: Before the Intervention, 1 Month, 2 and 3 Months after the Intervention. Method of measurement: Blood Visual Assessment Questionnaire. The Severity of Menstrual Cramps. Timepoint: Before the Intervention, 1 Month, 2 and 3 Months after the Intervention. Method of measurement: Visual Analogue Scale. Satisfaction with Treatment. Timepoint: After the Intervention. Method of measurement: Questionnaire. Complications. Timepoint: After the Intervention. Method of measurement: Check list. Gonabad University of Medical Sciences Approved 2020-05-17 Ethics committee of Gonabad University of Medical Sciences No. 79, Ranjbar Ave., West Taleghani Bojnourd North Khorasan Iran (Islamic Republic of)