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IRCT20220408054455N1 IRCT 2022-07-27 Tehran University of Medical Sciences The effect of Achillea Cretica herbal medicine on pain and size of endometrial lesions in patients. Comparison of the effect of Achillea Cretica herbal treatment with Dinogest on the pain and size of endometriosis lesions in patients referred to Arash Hospital. 2022-07-06 anticipated 80 Complete https://irct.ir/trial/63728 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our sample size is 80 people, with 40 people in each group. We will use the block randomization method by using: www.sealedenvelope.com. The number of blocks considered is 4, Blinding description: The random assignment list of patients is only available to the clinic secretary. To hide the random allocation process, the treatment sequence card is written in order, then the cards will be placed in sealed envelopes. On each envelope, a random 10-digit code is written without order and frame, which is the relevant patient identification number, and only the design methodologist will be aware of the relevant code. When the doctor announces that a patient is eligible, the clinic secretary provides the envelope to the physician and the desired treatment is performed according to the type mentioned in the envelope Patients do not know the type of syrup they receive and one group is given a placebo and the other group is given medicine. The final results of the study will be reviewed by a physician who is unaware of the type of intervention. For statistical analysis, a statistician who does not know how to assign individuals to groups is used. 3 Endometriosis. Intervention 1: Intervention group: Women aged 18 to 45 years with pain associated with endometriosis, who receive Achillea cretica syrup from Noush Daroo Toosan Salamat Company in addition to one dinogest tablet 2 grams per day for three months. Intervention 2: Control group: Women aged 18 to 45 years with pain associated with endometriosis, who receive placebo Achillea cretica syrup from Noush Daroo Toosan Salamat Company in addition to one dinogest tablet 2 grams per day for three month. 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 more information.
public Soheila Sadat Moosavifar
Arash hospital_Baqdarnia st_East Farjam st_Tehranpars st
Tehran Iran (Islamic Republic of) 1653915981 +98 912 633 5414 soheilamoosavifar@gmail.com Tehran University of Medical Sciences scientific Soheila Sadat Moosavifar
Arash hospital_Baqdarnia st_East Farjam st_Tehranpars st
Tehran Iran (Islamic Republic of) 1653915981 +98 912 633 5414 soheilamoosavifar@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women 18 to 45 years old with pain associated with endometriosis 18 years 45 years Female Pregnancy Breastfeeding The need for endometriosis surgery treatment Amenorrhea within 3 months prior to enrollment Previous use of hormonal agents (e.g., gonadotropin agonists less than 6 months ago, progesterone or danazol less than 3 months ago, or oral contraceptives 1 month before screening) Abnormal findings in gynecological examination Risk factors for decreased bone density (e.g., family history of osteoporosis or use of anticonvulsants or corticosteroids) N80 Endometriosis Treatment - Drugs Treatment - Drugs Intervention group: Women aged 18 to 45 years with pain associated with endometriosis, who receive Achillea cretica syrup from Noush Daroo Toosan Salamat Company in addition to one dinogest tablet 2 grams per day for three months. Control group: Women aged 18 to 45 years with pain associated with endometriosis, who receive placebo Achillea cretica syrup from Noush Daroo Toosan Salamat Company in addition to one dinogest tablet 2 grams per day for three month Degree of dysmenorrhea using visual pain ruler. Timepoint: At the beginning of the study and three months after starting treatment. Method of measurement: Using visual pain ruler. Degree of dyspareunia using visual pain ruler. Timepoint: At the beginning of the study and three months after starting treatment. Method of measurement: Using pain ruler. Degree of pelvic pain using pain ruler. Timepoint: At the beginning of the study and three months after starting treatment. Method of measurement: Using pain ruler. Size change of Endometriosis lesions by Sonography or Laparascopy. Timepoint: At the beginning of the study and three months after starting treatment. Method of measurement: By performing ultrasound or diagnostic laparoscopy. Number Change of endometriosis lesions by performing ultrasound. Timepoint: At the beginning of the study and three months after starting treatment. Method of measurement: By performing ultrasound or diagnostic laparoscopy. Tehran University of Medical Sciences Approved 2021-11-10 Ethics committee of school medicine, Tehran University of Medical Science Arash Hospital, Baqdarnia St., East Farjam St., Tehranpars Tehran Tehran Iran (Islamic Republic of)