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IRCT20121228011912N5 IRCT 2023-05-10 Mashhad University of Medical Sciences Investigating the effect of standard treatment of classical medicine and embedding in controlling dysmenorrhea and dyspareunia caused by endometriosis in women Investigating the effect of standard treatment of classical medicine and embedding in controlling dysmenorrhoea and dysparonychia caused by endometriosis in women. 2023-05-22 anticipated 50 Complete https://irct.ir/trial/69650 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the online site https://www.sealedenvelope.com, random allocation will be placed in two groups: A, classical medicine, and B, embedding. Randomization will be done based on Block Randomization with blocks of 4. The random allocation of 12 blocks of 4 will be as follows. The prepared blocks will be placed in the envelope. One of the envelopes will be randomly selected according to the order of patients' arrival, and based on the obtained blocks, 4 patients will be assigned to two groups, Blinding description: Using the online site https://www.sealedenvelope.com, random allocation will be placed in two groups: A, classical medicine, and B, embedding. Randomization will be done based on Block Randomization with blocks of 4. The random allocation of 12 blocks of 4 will be as follows. The prepared blocks will be placed inside the envelope. According to the order of patients' entry, one of the envelopes will be randomly selected and based on the obtained blocks, 4 patients will be assigned to two groups. Then, the collaboration, which is blind to the type of interventions, will check all patients in terms of entry and exit criteria, and then Forms and questionnaires are completed and primary and secondary outcomes are determined for those eligible. 3 dysmenorrhea and dyspareunia caused by endometriosis. Intervention 1: Intervention group: Embedding in women with dysmenorrhoea and dysparonychia caused by endometriosis in reproductive age. Acupuncture embedding is a new and emerging method developed in the fields of acupuncture and embedding needle. This method has immediate and long-lasting effects on the human body, compensates for the short duration of acupuncture stimulation and reduces the number of times patients visit the doctor. Intervention 2: Intervention group: Intervention group: The classical medicine group will be treated with one continuous and regular daily LD pill for a period of three months and from the same day (the first day of the menstrual cycle). Yes - There is a plan to make this available What will be shared: The statistical details of the data will be mentioned in the published article. When: After finishing research To whom: All those who have access to the published article or with the supervisory permission of the Vice Research of Mashhad University of Medical Sciences Conditions: With the request of the responsible researcher and the consent of the University Research Council and only for survey purposes without any possibility of exploiting the content of the data. Where to obtain: After printing the article to the responsible author and before printing, if required by relevant authorities, to the responsible researcher How to obtain: By means if Vice research of Mashhad University of Medical Science Comments:
public Dr. Hamidreza Bahrami-Taghanaki
Ebne Sina Street
Mashhad Iran (Islamic Republic of) 9184166750 +98 51 3884 8931 bahramihr@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Hamidreza Bahrami-Taghanaki
Ebne Sina street
Mashhad Iran (Islamic Republic of) 9184166750 +98 51 3841 1538 bahramihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, firm and motionless uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules) Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during diagnostic laparoscopy during the previous 12 months Dysmenorrhea complaint with EAPP score >30 or >40 normal pap smear Age 18-45 years Informed written consent to participate in the study 18 years 45 years Female Unwillingness to continue the research Non-adherence to the provided treatment regimen and incorrect or incomplete use of medication Occurrence of any complications attributed to drug use (especially allergies) Endometriosis who were treated with GNRH agonist less than 6 months ago, or danazol or progesterone pills less than 3 months ago, or birth control pills less than one month ago Breastfeeding, pregnancy. Cancers of the uterus, ovaries, cervix and high-grade intraepithelial lesions N80.9 Endometriosis, unspecified Treatment - Devices Treatment - Other Intervention group: Embedding in women with dysmenorrhoea and dysparonychia caused by endometriosis in reproductive age. Acupuncture embedding is a new and emerging method developed in the fields of acupuncture and embedding needle. This method has immediate and long-lasting effects on the human body, compensates for the short duration of acupuncture stimulation and reduces the number of times patients visit the doctor. Intervention group: Intervention group: The classical medicine group will be treated with one continuous and regular daily LD pill for a period of three months and from the same day (the first day of the menstrual cycle). Dysmenorrhea and dyspareunia. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months later. Method of measurement: It will be evaluated using the EAPP checklist scale. Anti-Müllerian hormone serum level and antral follicle count. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months later. Method of measurement: Measurement of anti-Müllerian hormone serum level and antral follicle count by ultrasound. Quality of Life. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months later. Method of measurement: Short form of World Health Organization quality of life questionnaire. Mashhad University of Medical Sciences Approved 2023-04-07 Mashhad University of Medical Sciences (Research Ethics Committee) 3rd floor - Abuzar qafari Bulv - Abuzar qafari 38- Ahmad Abad Ave. mashhad Razavi Khorasan Iran (Islamic Republic of)