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IRCT20220108053669N4 IRCT 2024-01-14 Mazandaran University of Medical Sciences Investigating the effectiveness of oral tablet based on the Cuscuta epithymum on endometrioma The effectiveness of oral tablet based on the Cuscuta epithymum on the pelvic pain, the quality of life and the size of the ovarian cyst of patients with endometrioma 2024-01-21 anticipated 68 Complete https://irct.ir/trial/70854 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random method: random block We consider two intervention and control groups as A and B. If we consider blocks of 4 or 4 people (to reduce the possibility of error), we will have 6 situations as follows: 1.AABB, 2.ABAB, 3.ABBA, 4.BBAA, 5.BABA, 6.BAAB In any case, we assign a number from 1 to 6. Then, by throwing the dice, one state will be determined each time, and based on the order of that state, we will determine the drug or placebo.for example, if the number two comes in the first throw, that means ABAB mode. So first we put medicine number 1 on a can. Then a can containing placebo number 2, drug number 3 and placebo number 4. In the same way, we throw the dice 17 times (for a sample size of 68 people) and number the cans containing medicine and placebo. be unaware, Blinding description: The drug and placebo, which have the same size, color, taste, and smell, are provided to both groups in completely identical containers based on random allocation by the design partner, so none of the patients are aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used. 2-3 Endometrioma. Intervention 1: Intervention group: The VAS scale is also filled by the patient before the start of the treatment on all days of the period and three times during the day and night. The patient is given 60 tablets of Aftimone (made in the faculty of pharmacy of Mazandaran university of medical science) to be used after breakfast and dinner. Also, patients are allowed to take NSAIDS (with preference to mefenamic acid). After one month, the patients were visited again, the package of medicine and placebo was delivered, and 60 tablets of Aftimone were delivered to the tested group and placebo to the control group for the next month. At this stage, the EHP-30 questionnaire (endometrioma disease quality of life questionnaire) is filled again, and in case of possible side effects, the medication side effects form is also filled. Also, after taking the drug for one month, the patients will fill the VAS scale again on all the days of the period, three times during the day and night. The third visit was two months after the initial visit, the package of medicine and placebo was delivered, and the endometrioma disease quality of life questionnaire will be filled again. The VAS scale will also be filled by the patient at the end of two months of drug use and during the period three times a day. Repeated ultrasound is also performed to determine the size of the ovarian cyst, so that any changes in the size of the patients' endometrioma are investigated. Intervention 2: Control group: The VAS scale is also filled by the patient before the start of the treatment on all days of the period and three times during the day and night. The patient is given 60 tablets of placebo to be used after breakfast and dinner. Also, patients are allowed to take NSAIDS (with a preference for mefenamic acid). After one month, the patients were visited again, the package of medicine and placebo was delivered, and 60 tablets of Aftimone were delivered to the tested group and the placebo to the control group for the next month. At this stage, the EHP-30 questionnaire (endometrioma disease quality of life questionnaire) is filled again, and in case of possible side effects, the medication side effects form is also filled. Also, after taking the drug for one month, the patients will fill the VAS scale again on all the days of the period, three times during the day and night. The third visit was two months after the initial visit, the package of medicine and placebo was delivered, and the endometrioma disease quality of life questionnaire will be filled again. The VAS scale will also be filled by the patient at the end of two months of drug use and during the period three times a day. Repeated ultrasound is also performed to determine the size of the ovarian cyst so that any changes in the size of the patients' endometrioma are investigated. 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 It needs consultation.
public negar Abbasi Sarmadi
Aghdasieh
Tehran Iran (Islamic Republic of) 1956983873 +98 912 643 6775 negar.asarmadi@gmail.com Mazandaran University of Medical Sciences scientific Seyde Sedighe Yousefi
Khazar Blvd
Sari Iran (Islamic Republic of) 1956983873 +98 11 3324 3117 dr_ssyousefi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Endometriosis with pelvic pain and ovarian cyst over 2 cm Absence of Müllerian fibrosis adenomyosis and myoma Not taking medication such as painkillers Consent 20 years 45 years Female Patient dissatisfaction Occurrence of pregnancy Drug complication C54.1 Malignant neoplasm of endometrium Treatment - Drugs Treatment - Drugs Intervention group: The VAS scale is also filled by the patient before the start of the treatment on all days of the period and three times during the day and night. The patient is given 60 tablets of Aftimone (made in the faculty of pharmacy of Mazandaran university of medical science) to be used after breakfast and dinner. Also, patients are allowed to take NSAIDS (with preference to mefenamic acid). After one month, the patients were visited again, the package of medicine and placebo was delivered, and 60 tablets of Aftimone were delivered to the tested group and placebo to the control group for the next month. At this stage, the EHP-30 questionnaire (endometrioma disease quality of life questionnaire) is filled again, and in case of possible side effects, the medication side effects form is also filled. Also, after taking the drug for one month, the patients will fill the VAS scale again on all the days of the period, three times during the day and night. The third visit was two months after the initial visit, the package of medicine and placebo was delivered, and the endometrioma disease quality of life questionnaire will be filled again. The VAS scale will also be filled by the patient at the end of two months of drug use and during the period three times a day. Repeated ultrasound is also performed to determine the size of the ovarian cyst, so that any changes in the size of the patients' endometrioma are investigated. Control group: The VAS scale is also filled by the patient before the start of the treatment on all days of the period and three times during the day and night. The patient is given 60 tablets of placebo to be used after breakfast and dinner. Also, patients are allowed to take NSAIDS (with a preference for mefenamic acid). After one month, the patients were visited again, the package of medicine and placebo was delivered, and 60 tablets of Aftimone were delivered to the tested group and the placebo to the control group for the next month. At this stage, the EHP-30 questionnaire (endometrioma disease quality of life questionnaire) is filled again, and in case of possible side effects, the medication side effects form is also filled. Also, after taking the drug for one month, the patients will fill the VAS scale again on all the days of the period, three times during the day and night. The third visit was two months after the initial visit, the package of medicine and placebo was delivered, and the endometrioma disease quality of life questionnaire will be filled again. The VAS scale will also be filled by the patient at the end of two months of drug use and during the period three times a day. Repeated ultrasound is also performed to determine the size of the ovarian cyst so that any changes in the size of the patients' endometrioma are investigated. The effect of drugs on patients pain. Timepoint: Monthly since intervention, two months. Method of measurement: VAS(Visual Analogue Scale). Drug effect on ovarian cyst size of patient. Timepoint: Two month since the beginning of intervention. Method of measurement: sonography. Drug effect on the quality of life of patients. Timepoint: Monthly since intervention, two month. Method of measurement: EHP-30 Questionnaire. Drug effect on the amount of painkillers usage in patients. Timepoint: Monthly since intervention, two month. Method of measurement: asking from patients. Mazandaran University of Medical Sciences Approved 2023-02-05 Ethics and registration committee in clinical trial center of Iran Sari, Jouibar interaction, Valiasr boulvard Sari Mazandaran Iran (Islamic Republic of)