]>
IRCT20221017056209N1 IRCT 2022-11-22 Gonabad University of Medical Sciences Comparison of the effect of medroxyprogesterone acetate and black seed extract on the symptoms of polycystic ovary syndrome in adolescent girls Comparison of the effect of medroxyprogesterone acetate and black seed extract on the symptoms of polycystic ovary syndrome in adolescent girls 2022-10-22 anticipated 116 Complete https://irct.ir/trial/66370 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done based on the randomization method of permutation blocks with variable sizes of 2 and 4. In this way, the randomization list will be determined (www.sealedenvelope.com)by the analyst. Opaque sealed envelopes with random sequence will be used for concealment. 1 Polycystic ovary syndrome. Intervention 1: Control group: Receiving medroxyprogesterone, taking 10 mg medroxyprogesterone tablets every month once a day from the 14th day of the cycle for 10 nights for 4 months. Intervention 2: Intervention group: Receiving black seeds, two capsules of 500 mg (1000 mg) of black seeds continuously until the fourth month from the beginning of the intervention. Yes - There is a plan to make this available What will be shared: Print the article When: After printing the article To whom: All people Conditions: Conduct future studies Where to obtain: internet How to obtain: Searching for article titles on the Internet Comments:
public Akram Ashouri
Imam Khomeini
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 a.ashouri1369@gmail.com Gonabad University of Medical Sciences scientific Narjes Bahri
Hmam Khomeini
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 nargesbahri@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Age range 12-18 years 2 years have passed since the start of menstruation Having the written consent of the teenager and her parents to participate in the study Ultrasound-confirmed polycystic ovary according to the Amsterdam criteria Absence of other causes of hyperandrogenism such as non-classical congenital adrenal hyperplasia, Cushing's syndrome (based on clinical history and participant's symptoms and statements), body mass index 25-19 Not using hormonal drugs in the last three months Not taking drugs that interact with medroxyprogesterone acetate, including amphetamine, thyroid drugs, diphenhydramine, ciprofloxacin, clofin, duloxetine, estradiol, omega-3 saturated fatty acids, lesilalopram, pregabalin, levonorgestrel, montelukast, levothyroxine, testosterone, cyanocobalamin. , ascorbic acid, colcalcinol, multivitamin, sertraline, cetirizine Insensitivity to black seed and medroxyprogesterone (according to the comment of the participant) Not suffering from diseases such as hypothyroidism, hyperprolactinemia with kidney, heart, liver, bone diseases, pituitary tumor, cancer and diabetes (based on clinical history and participants' statements) Not using tobacco and drugs (based on the participants' statements) No history of surgery on one or both ovaries There is no history of stressful events in the last three months (such as the death of a family member, accident, sexual violence, robbery) according to the teenager's self-report and parents' statements. 12 years 18 years Female Unwillingness to participate in the study E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Control group: Receiving medroxyprogesterone, taking 10 mg medroxyprogesterone tablets every month once a day from the 14th day of the cycle for 10 nights for 4 months Intervention group: Receiving black seeds, two capsules of 500 mg (1000 mg) of black seeds continuously until the fourth month from the beginning of the intervention Severity of polycystic ovary syndrome symptoms. Timepoint: The beginning of the study (before the intervention), 16 weeks after the intervention. Method of measurement: Ovarian volume ultrasound, LH test, GTT 1hr, GTT 2hr, total testosterone, fasting blood sugar, dihydroepiandrosterone sulfate or DHEA-S and androgen levels (testosterone and dihydroepiandrosterone sulfate or DHEA-S). Gonabad University of Medical Sciences Approved 2022-08-26 Ethics Committee of Gonabad University of Medical Sciences Imam khomeini Gonabad Razavi Khorasan Iran (Islamic Republic of)