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IRCT20181030041503N6 IRCT 2022-12-20 Mashhad University of Medical Sciences the effect cabergoline on reducing pain in endometriosis patients the effect of dopamine agonists (cabergoline) on reducing pain in endometriosis patients 2022-09-23 anticipated 80 Complete https://irct.ir/trial/65818 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the permutation blocks method was used to generate the sequence of random assignments of people to the studied groups. A random allocation sequence of people was done using Random Allocation Software and a block size of four. The permutation block method is one of the random allocation methods in which each block is selected as an integer multiple of the number of studied groups. In this study, there are four blocks: AABB, ABAB, BBAA, and BABA. One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second person will be assigned to group A, and the third and fourth person will be assigned to group B. And this process continues until all samples are allocated. The feature of this method is that the two study groups will have equal numbers. Random Allocation Software is free software for creating a random sequence using scientific methods including the permutation block method for allocating subjects to treatment groups, which was developed by Dr. Mahmoud Saghaei (https://www.saghaei.net), Blinding description: The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the. 3 Endometriosis. Intervention 1: Intervention group: Patients with endometriosis who will be given dopamine agonists (cabergoline) 0.5 milligrams twice a week for three months. Intervention 2: Control group: Patients with endometriosis who will be given dingiest 2 milligrams once a day for three month. 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 I am looking into the matter
public Elahe Khaleghzadeh
Bahonar
Mashhad Iran (Islamic Republic of) 9178143179 +98 51 3614 4942 elahekhaleghzadeh@gmail.com Mashhad University of Medical Sciences scientific Malihe Mahmoudinia
No. 7, Saremi 24/1 Ave., Hashemieh Blvd.
Mashhad Iran (Islamic Republic of) 9135913556 +98 51 3882 9878 mahmoudiniam@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 18 years 45 years Female Endometriosis treated less than 6 months ago with a GNRH agonist or less than 3 months ago danazol or progesterone tablets or less than 1 month ago with oral contraceptives. Severe pain unrelieved by Cabergoline necessitating the use of other analgesics lack of willingness to continue in the study non-adherence to the treatment regimen any adverse reactions to the medication (particularly allergies) Sensitivity to the medication and incorrect medication intake in the control group N80 Endometriosis Treatment - Drugs Treatment - Drugs Intervention group: Patients with endometriosis who will be given dopamine agonists (cabergoline) 0.5 milligrams twice a week for three months. Control group: Patients with endometriosis who will be given dingiest 2 milligrams once a day for three month. Severe dysmenorrhea pain. Timepoint: On the first day of menstruation and at the end of the first, second and third month of treatment. Method of measurement: By 10-point visual analogue scale (VAS). Mashhad University of Medical Sciences Approved 2022-07-02 Mashhad university of medical sciences Ethics committee Vice chancellor of Research, Mashhad university of Medical Sciences, Mashhad University of Medical Sciences ,University Avenue.Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)