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Evaluation of the Effect of Oral nutritional Consumption of food products (Cinnamon, Fennel, Cumin & Grapes syrup) on Metabolic and Hormonal Indices and Quality of Life

Evaluation of the Effect of Oral nutritional Consumption of food products (Cinnamon, Fennel, Cumin & Grapes syrup) on Metabolic and Hormonal Indices and Quality of Life in Women with Polycystic Ovary Syndrome (PCOS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250830067055N1
Enrollment
80
Registered
2025-12-25
Start date
2025-11-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Polycystic ovary syndrome.

Interventions

Intervention 1: Intervention group: Consuming herbal medicine Food product containing cinnamon, fennel, cumin, and grape juice, 85 grams are prepared daily as a breakfast meal for 90 days and are prov

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 44 Years

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

MeasureTime 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

MeasureTime 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

Public ContactDr. Maryam Shayesteh

Islamic Azad University

dr.maryamshayesteh@yahoo.com+98 912 622 0307

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026