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IRCT20140111016161N10 IRCT 2023-06-21 Tehran University of Medical Sciences Investigating the effect of prednisolone Investigating the effect of prednisolone on pelvic pain in women with deep endometriosis 2023-07-13 anticipated 60 Complete https://irct.ir/trial/70427 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our sample size is 60 people, with 30people in each group.The unit of study is the individual. We will use the block randomization method by using: www.sealedenvelope.com. The number of blocks considered is 4, Blinding description: The list of random allocation of patients is only at the disposal of the clinic nurse. In order to hide the random allocation process, the sequence of treatments will be written on60 cards in order. Then the cards will be placed inside sealed envelopes. When the doctor qualifies the patient to enter Determined for the study, the nurse provides the doctor with the envelope related to the type of intervention. In order to check the outcome, a doctor who was unaware of the type of intervention is used. Also, for data analysis, a statistician who is separate from the study process and from all The procedures performed are used in an uninformed manner.The study is double-blind. The patient is also unaware. 3 Endometriosis. Intervention 1: Intervention group : Patients use 2 tablets of prednisolone 5 mg (Iran Hormone Company) and one tablet of Verogest 2 mg (Ati Pharmed Company) daily for up to 3 months continuously. Intervention 2: Control group: Patients use 2 tablets of placebo and one tablet of Verogest 2 mg (Ati Pharmed Company) daily for up to 3 months continuously. 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 is not yet known if there will be a plan to make this available
public Reyhaneh Hosseini
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 212177719922 r-hosseini@tums.ac.ir Tehran University of Medical Sciences scientific Reyhaneh Hosseini
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 212177719922 r-hosseini@tums.ac.ir Arash Women 's Hospital , Tehran University of Medical sciences Iran (Islamic Republic of) confirm with trans vaginal / trans rectal ultra sonography candidate for medical therapy At least one year after surgical treatment 18 to 45 years no desire to get pregnant in the last 3 months 18 years 45 years Female Oligomenorrhea for three months or more Primary need for endometriosis surgical treatment Use of other hormonal agents during the study period Abnormal findings in women's examination except endometriosis Endometrioma above 5 cm Contraindications for glucocorticoid use N80 Endometriosis Treatment - Drugs Placebo Intervention group : Patients use 2 tablets of prednisolone 5 mg (Iran Hormone Company) and one tablet of Verogest 2 mg (Ati Pharmed Company) daily for up to 3 months continuously. Control group: Patients use 2 tablets of placebo and one tablet of Verogest 2 mg (Ati Pharmed Company) daily for up to 3 months continuously. Dyspareunia. Timepoint: Before and 3 months after treatment starting. Method of measurement: Visual analogous scale. Dysmenorrhea. Timepoint: Before and 3 months after treatment starting. Method of measurement: Visual analogous scale. Dyschezia. Timepoint: Before and 3 months after treatment starting. Method of measurement: Visual analogous scale. Tehran University of Medical Sciences Approved 2023-05-23 Ethics committee of Tehran University of Medical Science Qods street , Keshavarz Bulevar Tehran Tehran Iran (Islamic Republic of)