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IRCT20211201053241N1 IRCT 2022-01-01 Iran University of Medical Sciences Efficacy of Proscure on dysmenorrhea Efficacy of Proscure capsule on dysmenorrhea in known cases of endometriosis 2021-12-21 anticipated 90 Complete https://irct.ir/trial/60642 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, people are divided into two groups: moderate and severe. Then in each category, randomization is done by block method. First, 4 blocks of A and B are written. Then, with the help of a random number table (Excel program), the blocks are randomly selected and lined up side by side to complete the desired sample size. A random list is provided to the person performing the illness. The patient and the person receiving the disease are not aware of the type of drug A and B, and the placebo drug is similar in appearance. Also, the data analyzer is not aware of types A and B (three-way blind study). For allocation concealment, letter envelopes are used in the package so that the number of the person referring to the envelope and the type of medicine he should receive is written in the envelope, Blinding description: The table of random numbers prepared by a respected statistical expert is available to the researcher. The medicine and placebo packs are packaged in a similar way and the table numbers are repeated and recorded on them and the consulting pharmacist is in the process of this packaging. In this way, with the arrival of the patient who fills in the forms, the pack is followed by the relevant number delivered. 3 Endimetriosis. Intervention 1: Intervention group: Women 20 to 45 years old with dysmenorrhea due to endometriosis; The intervention is the prescription of Proscore drug produced by Gol Daroo company that the patient consumes morning and night in clean days. First, the pain and quality of life questionnaire is filled in by the therapist, then the package containing the medicine is delivered, the patient is visited every 4 weeks until the three menstrual cycles, and finally the questionnaires will be filled in again. Intervention 2: Control group: Women 20 to 45 years old with dysmenorrhea due to endometriosis; The intervention is the prescription of Proscore drug produced by Gol Daroo company that the patient consumes morning and night in clean days. First, the pain and quality of life questionnaire is filled in by the therapist, then the package containing the medicine is delivered, the patient is visited every 4 weeks until the three menstrual cycles, and finally the questionnaires will be filled in again. Yes - There is a plan to make this available What will be shared: All data can be shared after identifying individuals. When: Access starts six months after printing the results To whom: Academic researchers Conditions: For sample use in larger studies Where to obtain: Email the scientific interface of the project called Elham Akhtari How to obtain: An email will be sent and it will be done within a week. Comments:
public Elham Akhtari
Persian Medicine school, Behesht Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5563 9667 Eli.akhtari@gmail.com Iran University of Medical Sciences scientific Elham Akhtari
Persian Medicine School, Behesht Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5563 9667 Eli.akhtari@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of Endometriosis Gynecological refer VAS bigger than or equal 3 No need to emergency management Age between 20-45 20 years 45 years Female Wish to pregnancy in 3 months later breast feeding need to emergency no attempt to herbal medicine N80.0 Endometriosis of uterus Treatment - Drugs Treatment - Drugs Intervention group: Women 20 to 45 years old with dysmenorrhea due to endometriosis; The intervention is the prescription of Proscore drug produced by Gol Daroo company that the patient consumes morning and night in clean days. First, the pain and quality of life questionnaire is filled in by the therapist, then the package containing the medicine is delivered, the patient is visited every 4 weeks until the three menstrual cycles, and finally the questionnaires will be filled in again. Control group: Women 20 to 45 years old with dysmenorrhea due to endometriosis; The intervention is the prescription of Proscore drug produced by Gol Daroo company that the patient consumes morning and night in clean days. First, the pain and quality of life questionnaire is filled in by the therapist, then the package containing the medicine is delivered, the patient is visited every 4 weeks until the three menstrual cycles, and finally the questionnaires will be filled in again. Dysparunia based on VAS questionare. Timepoint: The beginning of the study and then the end of the study at the end of three months of treatment. Method of measurement: VAS questionaire. Iran University of Medical Sciences Approved 2021-11-21 Ethics committee of Iran University of Medical Sciences University of Persian Medicine, Behesht Street, Vahdat eslami Avenue, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)