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IRCT20110606006709N25 IRCT 2023-05-18 Tabriz University of Medical Sciences Comparing the effect of nettle extract with COCs on the improvement of clinical and paraclinical symptoms of polycystic ovary syndrome. Comparative efficacy of Nettle (Urtica Dioica) with Combined Oral Contraceptive pills (COCs), on Clinical and Paraclinical Symptoms of Polycystic Ovary Syndrome (PCOS): A Triple Blind Randomized Controlled Trial 2023-05-22 anticipated 60 Complete https://irct.ir/trial/66760 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be placed in two intervention and control groups using a random block method with a block size of 6 and with a 1:1 allocation sequence. The allocation sequence will be determined by a person not involved in the study using G-Power software, placed in consecutively numbered opaque envelopes to conceal drug or placebo allocation, and prepared according to the allocation sequence by The person not involved in the research will be done from number 1 to 60, Blinding description: Medicines (nettle extract and LD) will be prepared by the pharmaceutical company in a completely similar form in terms of shape, color and smell. The participant, researcher, data analyst will be unaware of the type of intervention received. 3 Clinical and paraclinical symptoms of polycystic ovary syndrome. Intervention 1: Nettle extract capsules (containing flavonoids, tannins and sterols) in the number of 30 capsules, one daily for three cycles, which will be prepared and packaged by Sina Navandish Company. Intervention 2: Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), in the number of 21 capsules along with 9 capsules containing an ineffective substance to be consumed in a cycle of 30 capsules per day for three cycles, which will be prepared and packaged by Sina Navandish Company . 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 after the completion of the project the decision will be made
public Faride Majdi
Faculty of Nursing and Midwifery, South Shariati St
Tabriz Iran (Islamic Republic of) 5135963777 +98 41 3523 0741 faridemajdi211@gmail.com Tabriz University of Medical Sciences scientific Mahnaz Shahnazi
South Shariati Street, Faculty of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 shahnazimahnaz@ gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirming the diagnosis of PCOS according to the Rotterdam criteria (clinical or biochemical hyperandrogenism, menstrual cycle disorders or polycystic ovary ultrasound signs) Age 18 to 40 years Being literate in reading and writing BMI between 18.5 and 30 Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months Not wanting to get pregnant 18 years 40 years Female Relative and absolute contraindications of LD tablets (having blood pressure above 14/9, smoking and alcohol use, pregnancy or breastfeeding, alcohol and smoking use, suspicion of breast cancer, coronary heart disease, endometrial carcinoma, etc.) Women undergoing infertility treatment at the time of study. Previous surgery on one or both ovaries. Allergy to nettle Disorders that cause hyperandrogenism (having Cushing's syndrome, adrenal hyperplasia, androgen-producing tumors, etc.) E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Nettle extract capsules (containing flavonoids, tannins and sterols) in the number of 30 capsules, one daily for three cycles, which will be prepared and packaged by Sina Navandish Company. Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), in the number of 21 capsules along with 9 capsules containing an ineffective substance to be consumed in a cycle of 30 capsules per day for three cycles, which will be prepared and packaged by Sina Navandish Company . Serum levels of DHEA and total testosterone. Timepoint: Before the start of the intervention and 3 months after the intervention. Method of measurement: By ELISA method in the central laboratory. Average score of hirsutism. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Ferriman–Gallwey scale. Normalization of menstrual cycles. Timepoint: Before the intervention, one month, two months, and three months after the intervention. Method of measurement: Questionnaire made by the researcher and Higham's chart. Serum level of fasting blood sugar. Timepoint: Before the start of the intervention and and 3 months after the intervention. Method of measurement: By spectrophotometric method in the central laboratory. Serum levels of gonadotropins (FSH and LH). Timepoint: Before the start of the intervention and and 3 months after the intervention. Method of measurement: By ELISA method in the central laboratory. Tabriz University of Medical Sciences Approved 2023-05-09 Ethics Committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)