Polycystic ovary syndrome.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 18 to 44 years who have (PCOS) according to the Rotterdam criteria and diagnosed by a gynecologist in the clinic who have at least two of the following three criteria: Hyperandrogenism (clinical or biochemical) Menstrual disorders (oligomenorrhea or amenorrhea) Presence of polycystic ovaries (PCOS) (based on ultrasound) None of the participants took any chemical medication during the study.
Exclusion criteria
Exclusion criteria: Participants with the following conditions will be excluded from the study: Are pregnant or planning to become pregnant within the next three months Are taking certain medications such as metformin, hormonal medications, or medications related to (PCOS) Have serious comorbidities such as type 1 or 2 diabetes, hypothyroidism, hyperprolactinemia33, or renal and adrenal insufficiency Are currently breastfeeding or have stopped breastfeeding for less than six months Are allergic to cinnamon, fennel, or cumin plants Are allergic to grape juice??
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Change in menstrual cycle regularity including cycle length and number of menstrual cycles during the 3 months of intervention. Timepoint: Before the start of the intervention and 3 months later at the end of the intervention. Method of measurement: Outcome measurement method: Rotterdam diagnostic criteria, PCOSQ questionnaire, and menstrual cycle recording by the patient, and the quality of life measurement tool is the standard PCOSQ (Polycystic Ovary Syndrome Quality of Life Questionnaire), which is a valid and validated tool for assessing the quality of life of patients with PCOS.;Secondary outcome: changes in body mass index (BMI). Timepoint: Before the start of the intervention and 3 months later at the end of the intervention. Method of measurement: Outcome measurement method: Blood tests, Rotterdam diagnostic criteria, PCOSQ questionnaire, standard PCOSQ (Polycystic Ovary Syndrome Quality of Life Questionnaire), which is a valid and validated tool for assessing the quality of life of patients with PCOS.;Secondary outcome: Fasting blood sugar (FBS). Timepoint: Before the start of the intervention and 3 months later at the end of the intervention. Method of measurement: Blood tests.;Secondary outcome: Lipid profile (TG, LDL, HDL, total cholesterol). Timepoint: Before the start of the intervention and 3 months later at the end of the intervention. Method of measurement: Blood tests.;Secondary outcome: hormones (LH, FSH, testosterone, DHEAS). Timepoint: Before the start of the intervention and 3 months later at the end of the intervention. Method of measurement: Blood tests.;Secondary outcome: Quality of life based on PCOSQ questionnaire. Timepoint: Before the start of the intervention and 3 months later at the end of the intervention. Method of measurement: Outcome measurement method: Rotterdam diagnostic criteria, PCOSQ questionnaire, and the quality of life measurement tool is the standard PCOSQ (Polycystic Ovary Syndrome Quality of Life Quest | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body mass index (BMI). Timepoint: Measurement times: Before the intervention (baseline) and 3 months after the end of the intervention. Method of measurement: Blood tests, Rotterdam diagnostic criteria, PCOSQ questionnaire.;Fasting blood sugar (FBS). Timepoint: Measurement times: Before the intervention (baseline) and 3 months after the end of the intervention. Method of measurement: Blood tests.;Lipid profile (TG, LDL, HDL, total cholesterol). Timepoint: Measurement times: Before the intervention (baseline) and 3 months after the end of the intervention. Method of measurement: Blood tests.;Hormones (LH, FSH, testosterone, DHEA-S). Timepoint: Measurement times: Before the intervention (baseline) and 3 months after the end of the intervention. Method of measurement: Blood tests.;Life quality. Timepoint: Measurement times: Before the intervention (baseline) and 3 months after the end of the intervention. Method of measurement: Rotterdam Diagnostic Criteria, PCOSQ Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Islamic Azad University