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NCT06642363

The Effectiveness of Astaxanthin Supplementation on the Clinical Symptoms and Cardio-metabolic Profile in Women with Polycystic Ovary Syndrome

Recruiting now Phase 1 Last updated 17 October 2024
What this trial tests

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.

Timeline
22 July 2024
Primary endpoint
22 July 2025
22 July 2025

Quick facts

Lead sponsorIsfahan University of Medical Sciences
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposescreening
Enrollment44
Start date22 July 2024
Primary completion22 July 2025
Estimated completion22 July 2025
Sites1 location across Iran

Drugs / interventions tested

Conditions studied

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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