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Tests treatment safety and results for PCO - Polycystic Ovaries
Official title The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT06642363
What this study is testing
What is Subjects in the intervention group will receive one capsule containing 10 mg Astaper day made by the "Zyest Technology Tarawat Zendig" institute in Iran. The dosage of ASX is determined based on the s?
Subjects in the intervention group will receive one capsule containing 10 mg Astaper day made by the "Zyest Technology Tarawat Zendig" institute in Iran. The dosage of ASX is determined based on the s is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pco - polycystic ovaries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Abstract Background: This trial aims to investigate the effect of 12 weeks of 10 mg/day astaxanthin (ASX) administration compared with the control group on insulin sensitivity, lipid profile, circulating MDA levels, severity of hirsutism, and depression in women with Polycystic Ovary Syndrome (PCOS). Methods: This manuscript will outline the design, methodology, and potential clinical implications of ASX supplementation in eligible women with PCOS and a body mass index of 25-35 kg/m2, who are referred to the gynecologist clinic in Isfahan, Iran, during 2024-2025.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Age 18 - 45 years
- Clinical diagnosis of polycystic ovary syndrome
- Have a body mass index of 25-35 kg/m 2
- Absence of pregnancy and breastfeeding
- No intake of medicine
You likely can't join if
- Consuming less than 80% of the total administered ASX supplements
- Ongoing pregnancy
- Changing their usual diet or eating habits or level of physical activity
- Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation
- Smoking or alcohol consumption
See the full eligibility criteria
- Age 18 - 45 years
- Clinical diagnosis of polycystic ovary syndrome
- Have a body mass index of 25-35 kg/m 2
- Absence of pregnancy and breastfeeding
- No intake of medicine
- Not willing to get pregnant during the study
- No presence of chronic inflammatory diseases or other endocrine disorders
- No current treatments except metformin
- No intake of dietary supplements within at last 2 previous months
- Consuming less than 80% of the total administered ASX supplements
- Ongoing pregnancy
- Changing their usual diet or eating habits or level of physical activity
- Presence of Skin or digestive allergy symptoms or any desired complications by intake of ASX supplementation
- Smoking or alcohol consumption
The study team makes the final eligibility decision.
Where it's taking place
- Isfahan, Isfahan, Iran
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Isfahan, Isfahan, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.