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IRCT20221111056469N1 IRCT 2022-11-16 Zahedan University of Medical Sciences Effectiveness of curcumin in endometriosis. Evaluation the effectiveness of the Curcumin as add-on to dienogest in patients with endometriosis. 2022-12-06 anticipated 86 Complete https://irct.ir/trial/66806 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sample size is 86 people, of which 43 people will be placed in each group. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The number of considered blocks is 6, Blinding description: The list of random allocation of patients will only be at the disposal of the plan's epidemiologist. In order to hide the random allocation process, random 10-digit codes are written on 86 paper labels without a specific order and framework, which is the identification number of the relevant treatment and only the project methodologist will be aware of the relevant code. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the patient with the package treatment plan. The person evaluating the intended outcomes is a third person who is unaware of the randomization 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. The list of random allocation of patients will only be at the disposal of the plan's epidemiologist. In order to hide the random allocation process, random 10-digit codes are written on 86 paper labels without a specific order and framework, which is the identification number of the relevant treatment and only the project methodologist will be aware of the relevant code. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the patient with the package treatment plan. The person evaluating the intended outcomes is a third person who is unaware of the randomization 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. N/A Endometriosis. Intervention 1: Control group: Control group: control group (dienogest and placebo) will receive a dose of 2 mg of dienogest daily along with placebo. Intervention 2: Intervention group: Intervention group: Patients in the intervention group (Dinogest and curcumin) will receive a dose of 2 mg dinogest daily. According to the panel of the European Food Safety Authority, the acceptable dose of curcumin is 3 mg per kilogram of body weight. be Patients in the intervention and control groups are prescribed the prescribed dose based on the patient's weight and the frequency of daily use. During the treatment, nanomicelle curcumin 80 and 40 mg of Sinacurcumin company is used. 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 There is no further information
public Mahjob Sargazi Taghazi
Zebashahr - Nasr Street - 18 Nasr - Middle of Milan
Zahedan Iran (Islamic Republic of) 9817979699 +98 54 3348 9817 Mahjobsargazi.taghazi@yahoo.com Zahedan University of Medical Sciences scientific Mahjob Sargazi Taghazi
Zibashahr-Nasr-Nasr 18- Mid Milan
Zahedan Iran (Islamic Republic of) 9817979699 +98 54 3348 9817 Mahjobsargazi.taghazi@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 45 years experiencing pain associated with endometriosis proven by ultrasound and examination and history No previous history of using hormonal agents Candidate to receive dinogest 18 years 45 years Female Pregnancy or breastfeeding Amenorrhea The need for surgery after the intervention Previous use of hormonal agents (such as GnRH agonists for 6 months, progestins, dienogest or danazol for 3 months or oral contraceptives for 1 month before the intervention) Abnormal findings in women's examination Abnormal cervical cytology smear in the last 3 months Taking narcotic painkillers before surgery on a daily basis for 2 weeks before surgery Additional surgeries performed or malignancy N80 Endometriosis Placebo Treatment - Drugs Control group: Control group: control group (dienogest and placebo) will receive a dose of 2 mg of dienogest daily along with placebo. Intervention group: Intervention group: Patients in the intervention group (Dinogest and curcumin) will receive a dose of 2 mg dinogest daily. According to the panel of the European Food Safety Authority, the acceptable dose of curcumin is 3 mg per kilogram of body weight. be Patients in the intervention and control groups are prescribed the prescribed dose based on the patient's weight and the frequency of daily use. During the treatment, nanomicelle curcumin 80 and 40 mg of Sinacurcumin company is used. Score Of The Quality of life questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 2 months later. Method of measurement: Specific Questionnaire of Quality of Life in Endometriosis Patient(Endometriosis Health Profile-30). Sexual performance score in the questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 2 months later. Method of measurement: Female Sexual Function index. Endometrioma lesion Size. Timepoint: At the beginning of the study (before the start of the intervention) and 2 months later. Method of measurement: Ultrasound and Medical Examination. Pain Score in the Questionnaire. Timepoint: At the beginning of the study (before the intervention) and 2 months later. Method of measurement: Pain Visual Analog Scale Questionnaire. Pain Score in the Questionnaire. Timepoint: At the beginning of the study (before the intervention) and 2 months later. Method of measurement: Pain Visual Analog Scale Questionnaire. Sexual performance score in the questionnaire. Timepoint: At the beginning of the study (before the intervention) and 2 months later. Method of measurement: Female Sexual Function Index. Quality of life score in the questionnaire. Timepoint: At the beginning of the study (before the intervention) and 2 months later. Method of measurement: Specific Questionnaire of Quality of life in Endometriosis Patient(Endometriosis Health Profile-30). Endometrioma lesion size. Timepoint: At the beginning of the study (before the intervention) and 2 months later. Method of measurement: Ultrasound and medical examination. Zahedan University of Medical Sciences Approved 2022-10-25 Ethics Committee of Zahedan University of Medical Sciences Sistan and Baluchestan Province, Zahedan, Integrating the campus of the University of Medical Sciences، doctor، Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)