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NCT06642363
The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome
Phase 1 trial testing 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 in PCO - Polycystic Ovaries in 44 participants. Currently enrolling.
22 July 2025
Quick facts
| Lead sponsor | Isfahan University of Medical Sciences |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | screening |
| Enrollment | 44 |
| Start date | 22 July 2024 |
| Primary completion | 22 July 2025 |
| Estimated completion | 22 July 2025 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- 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
- Placebo
Conditions studied
- PCO - Polycystic Ovaries — all drugs for PCO - Polycystic Ovaries →
- Obesity and Obesity-related Medical Conditions — all drugs for Obesity and Obesity-related Medical Conditions →
Sponsor
Isfahan University of Medical Sciences
Who can join
Adults 18 to 45, female only, with PCO - Polycystic Ovaries or Obesity and Obesity-related Medical Conditions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. Discussion: This study is one of the first attempts to assess the clinical efficacy of astaxanthin as an auxiliary treatment in PCOS patients, and will provide more evidence in this area. Trial registration number: Iran Clinical Trials (IRCT) website. (IRCT20231001059573N1)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06642363 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Isfahan University of Medical Sciences
- Last refreshed: 17 October 2024
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