Viewing Study NCT06417099



Ignite Creation Date: 2024-05-19 @ 5:35 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06417099
Status: RECRUITING
Last Update Posted: 2024-06-20
First Post: 2024-05-12

Brief Title: Efficacy of Dihydroartemisinin for Treating PCOS
Sponsor: Shanghai Zhongshan Hospital
Organization: Shanghai Zhongshan Hospital

Study Overview

Official Title: Therapeutic Efficacy of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The primary research hypothesis of this study is that dihydroartemisinin is effective in restoration of regular menstrual cycles of PCOS subjects who meet at least two of three Rotterdam Criteria Secondary research hypotheses include dihydroartemisinin is also effective in reducing androgen total immature follicles and anti-Mullerian hormone
Detailed Description: Polycystic ovary syndrome PCOS is a common reproductive endocrine metabolic disorder caused by genetic and environmental factors Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice In recent years artemisinin has also been reported to have significant anti-inflammatory anti-tumor and immune-modulating effects Our recent study revealed that artemisinin derivatives protect against PCOS development by inhibiting ovarian androgen production Consistently in a small pilot study dihydroartemisinin effectively reduced androgen levels reduced immature follicles and improved the estrous cycle in PCOS patients who strictly met all the three Rotterdam Criteria namely hyperandrogenism ovulation dysfunction and polycystic ovaries on ultrasound Nevertheless clinical diagnosis of PCOS can be established as long as a patient fulfill two of the three Rotterdam Criteria The present study aims to explore the therapeutic effects of dihydroartemisinin in patients with PCOS who met at least two of three 2 Rotterdam Criteria

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None