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IRCT20180404039187N11 IRCT 2023-07-29 Tabriz University of Medical Sciences The effect of Agnugol on painful symptoms of endometriosis and quality of life The effect of Agnugol on painful symptoms of endometriosis and quality of life: a randomized clinical trial 2023-04-21 anticipated 70 Complete https://irct.ir/trial/67003 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two groups of intervention (recipient of Agnugol tablets) and control (recipient of placebo) by random block method with the size of blocks of four and with allocation ratio of 1:1. Allocation sequence will be done by someone not involved in sampling and data collection. Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number to each of them AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6) 3) Choosing random numbers between 1 and 6 4) Defining the treatment assignment list For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5), Blinding description: This study is a three -way blind trial in which the researcher, the participant and the analyst will not know each group the person is in. The participant will be assigned to two intervention groups(recipients of Agnugol) and control groups(recipients of placebo). Allocation sequence will be done by someone not involved in sampling and data collection. to conceal the allocation, the drug and placebo will be numbered and packed in the same container and consecutively. At the researcher level, blindness will be done as the researcher give the medicine to patients on the basis of label A or B without knowing the nature of A, B and according to the randomized list. At the patient's level, blindness will be done as the patients do not know in which group (control or intervention group) they are in. At the analyst level, blindness will be done as analyst will analyze the data without knowing the intervention and control group. 3 endometriosis. Intervention 1: Agnugol tablet recipient at a dose of 3.2-4.8 mg once a day for 8 weeks. Intervention 2: placebo tablet recipient at the same dose and appearance once a day for eight weeks. 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 Its release schedule is not yet know.
public Elnaz Shaseb
Faculty of Pharmacy, Tabriz University of Medical Sciences, Golgasht Ave., Azadi Ave
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3335 5921 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences scientific Elnaz Shaseb
Faculty of Pharmacy, Tabriz University of Medical Sciences, Golgasht Ave., Azadi Ave
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3335 5921 elnaz_shaseb_64@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with endometriosis whose disease has been diagnosed based on clinical symptoms and imaging (sonography) as well as previous documented evidence of endometriosis. Women with symptomatic endometriosis. Women who are in the age range of 18-49 years. They have not taken anti-inflammatory or hormonal drugs in the last three months. Don't have endometrial hypoplasia or neoplasia. Women who are married and sexually active. 18 years 49 years Female Women who are allergic to medicinal plants, especially the Lamiaceae family. Women suffering from gallstones, jaundice due to biliary obstruction and acute biliary colic. Women with digestive diseases. Women who suffer from inflammatory diseases or diseases associated with immune system defects such as rheumatoid arthritis, lupus, multiple sclerosis, etc. N74.8 Female pelvic inflammatory disorders in other diseases classified elsewhere Treatment - Drugs Placebo Agnugol tablet recipient at a dose of 3.2-4.8 mg once a day for 8 weeks placebo tablet recipient at the same dose and appearance once a day for eight weeks Quality of life of endometriosis patients. Timepoint: before investigation and 8 weeks after investigation. Method of measurement: questionnaire 30-EHP. Symptoms of pelvic pain and gynecology. Timepoint: before investigation and 8 weeks after investigation. Method of measurement: questionnaire ENDOPAIN-4D. Pain. Timepoint: the first 3 days of the next 3 menstrual cycles. Method of measurement: VAS ruler. Tabriz University of Medical Sciences Approved 2022-11-01 Ethics Committee of Tabriz university of medical sciences Research and technology dept, central building No.2, third floor, tabriz university of medical sciences, golgasht St, tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)