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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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221017056209N1
Enrollment
116
Registered
2022-11-22
Start date
2022-10-22
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

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:

Sponsors

Gonabad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkram Ashouri

Gonabad University of Medical Sciences

a.ashouri1369@gmail.com+98 51 5722 3028

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026