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The effect of a jujube and thyme formulation on oligomenorrhea in patients with polycystic ovary syndrome

Comparison of the effect of a Jujube and Thyme formulation and Metformin on oligomenorrhea in patients with polycystic ovary syndrome: a double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250803066744N1
Enrollment
80
Registered
2025-11-12
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Polycyctic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Patients take the jujube and thyme product of Barij Essence Company called Hemo Balance at a dose of 3 times a day, one tablespoon each time before meals (the dose

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women 18-40 years old Having polycystic ovary syndrome according to the Rotterdam criteria and diagnosed by an obstetrician and gynecologis Oligomenorrhea (at least two months) Body mass index (BMI) = 35

Exclusion criteria

Exclusion criteria: The presence of other causes of oligomenorrhea including hyperprolactinemia, hyper/hypothyroidism, congenital adrenal hyperplasia, structural or malignant disorders, etc. according to the opinion of the obstetrician and gynecologist The presence of uncontrolled cardiovascular, hepatic, renal, endocrine and metabolic diseases Use of anticoagulant drugs Use of hormonal drugs (oral contraceptives) Use of other medicinal herbs effective in menstrual disorders History of allergy to herbal medicines including thyme and jujube Being pregnant Intention to become pregnant Breastfeeding

Design outcomes

Primary

MeasureTime frame
Menstrual status (Menstrual timing and pattern). Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: Assessed based on patient self-report.;Average body mass index. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: using a scale and measuring tape. Patients were weighed with minimal clothing and no shoes, using a scale with a precision of 0.5 kg. Height was measured without shoes using a wall-mounted measuring tape with a precision of 1 cm. BMI was calculated by dividing weight (kg) by the square of height (m²).;Number of follicles and ovarian volume in uterine and ovarian ultrasound. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: Ultrasound assessment of the uterus and ovaries was performed by a gynecologist during the menstrual period (days 3–5) at the beginning and end of the study. The ovaries were evaluated for the number of follicles (more than 12 follicles with a size of 2–9 mm is diagnostic for PCOS) and ovarian volume (an ovarian volume greater than 10 mL indicates PCOS).;Quality of life index. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: The effect of treatment on the quality of life in patients with PCOS was assessed using the Polycystic Ovary Syndrome Questionnaire.;Insulin indices. Timepoint: On day 1 and after 90 daysafter drug administration. Method of measurement: Laboratory examination including fasting insulin and insulin resistance.;Drug-related adverse events. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: The Common Terminology Criteria for Adverse Events (a tool that defines and grades the severity of adverse events resulting from drug therapy or other medical interventions. It categorizes these events on a scale from 1 to 5 (mild, moderate, severe, life-threatening, and death)).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Nabipour

Iran University of Medical Sciences

yasmasiha99@gmail.com+98 21 5558 0388

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026