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Investigating the effect of Date Palm Pollen on women with polycystic ovary syndrome

The effect of Date Palm Pollen on follicogenesis and liver enzymes in women with polycystic ovary syndrome: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230531058351N1
Enrollment
40
Registered
2023-06-21
Start date
2023-09-22
Completion date
Unknown
Last updated
2023-06-26

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: Intervention group: participants in the intervention group received 400 mg Date Palm Pollen once a day after lunch for 12 weeks. After characterizing Date Palm Pollen native to Abadan

Sponsors

Educational and Research Vice-Chancellor of Abadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: To diagnose polycystic ovary syndrome according to the Rotterdam criteria, two of the following must be present: 1- Amenorrhea or reduced ovulation frequency Presence of hyperandrogenism based on clinical symptoms (hirsutism and male pattern hair loss) or laboratory (androgen increase) free or increased free androgen index) the presence of evidence of polycystic ovary in ultrasound.

Exclusion criteria

Exclusion criteria: People who use tobacco and alcohol. People suffering from chronic kidney, liver, lung diseases and chronic or acute inflammatory diseases (especially acute inflammation of the pancreas), thyroid dysfunction, heart valve disease, short bowel syndrome. Also, people with low ability of immune system (autoimmunity) are removed from the list of eligible people. These conditions are approved by the clinical consultant in the case of the studied subjects. Also, people who are allergic to medicine or placebo during the study. or taking chemotherapy drugs (tamoxifen) and corticosteroids, or drugs affecting blood sugar and lipids (insulin injections, statins, diuretics), antibiotics and vitamin supplements and omega 3, or suffering from one of the above-mentioned diseases Either they were admitted to the hospital or they had to change the dosage of the drugs they were taking, they were excluded from the study. To overcome the confounding factors, we use the general information questionnaire and the three-day record of people's food intake.

Design outcomes

Primary

MeasureTime frame
Alanine Aminotransferase(ALT). Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: VT3000 device will be used to measure liver enzymes.;Aspartate Aminotransferase(AST). Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: VT3000 device will be used to measure liver enzymes.;Alkaline Phosphatase(ALK-P). Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: VT3000 device will be used to measure liver enzymes.;17a hydroxy-progesterone. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones.;Progesterone. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones.;Androstenedione. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones.;Estrogen. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones.;LH. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones.;CBC. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: Blood tests are performed by means of TB counter machines.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh Karimi

Abadan University of Medical Sciences

samaneh_k_500@yahoo.com+98 61 5326 7800

Outcome results

None listed

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