Zhongshan Hospital Fudan University
Shanghai, 200032, China
NCT Number: NCT05465135
Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin also has some significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigators' previous studies discovered that Artemisinin dramatically reduced serum androgen levels and improved poly-cystic ovary syndrome(PCOS) in animals. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.
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Notify Me16 year–35 year
Female
Interventional
Phase 4
Shanghai, 200032, China
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by a combination of genetic and environmental factors. The pathogenesis of PCOS remains unclear. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin has significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigator's previous studies found that artemisinin and its derivatives could significantly promote uncoupling protein 1 (UCP1) transcription and the conversion of white fat to brown fat. Artemisinin derivatives upregulated the levels of genes critical for brown fat differentiation and function, accompanied by enhanced mitochondrial biosynthesis, demonstrating their potential to promote white fat browning and improve metabolism in rodent models. The investigators also observed that androgen levels in drug-induced PCOS rats were reduced, when treated with artemether analogs for prophylactic and therapeutic purposes, respectively. It is believed that the two core mechanisms in the pathogenesis of PCOS are excessive androgen synthesis and insulin resistance. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both serum androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms and control or even reverse the disease progression. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dihydroartemisinin 40mg three times a day for 12 consecutive weeks.
Time frame: 12 weeks
Periodical vaginal bleeding by questionnaire
Time frame: 12 weeks
Length, width and height of bilateral ovaries measured by B type ultrasound
Time frame: 12 weeks
Total number of follicles with diameters <10 mm measured by B type ultrasound
Time frame: 12 weeks
Measurement of serum total testosterone
Time frame: 12 weeks
Measurement of serum AMH
Time frame: 12 weeks
Measurement of serum SHBG
Time frame: 12 weeks after drug intervention
Measurement of serum DHEA
Shanghai Zhongshan Hospital
Other
The Evaluation of the Effect of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome
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