Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome

In brief

The purpose of this study is to see if substances contained in ginger or aloe plants, called exosomes, will treat and improve the condition polycystic ovary syndrome

Key facts

Study ID

NCT03493984

Run by

University of Louisville

People needed

0

Starts

2019-10-01

Expected to finish

2020-05-01

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age 18-40 year
• Patients must have a confirmed diagnosis of PCOS according to the Rotterdam Criteria. At least 2 of the following 3 characteristics must be present: 1. Oligo-anovulation 2. Clinical and/or biochemical signs of androgen excess and 3. Polycystic ovarian morphology (PCOM) (defined by an increased number of small antral follicles [≥12 follicles that were <10 mm in diameter] or an increased individual ovarian volume [>10 cm3] in 1 or both ovaries. Disorders mimicking PCOS must also be excluded, including thyroid dysfunction, hyperprolactinemia, late-onset congenital adrenal hyperplasia, and ovarian or adrenal androgen-producing tumors.
• Of all subjects screened patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
• Ability to understand and willingness to sign a written informed consent document.
• Absence of life limiting medical conditions

You may not qualify if…

• • Pregnancy
• Known HIV
• Patients receiving immunosuppressive drugs
• Patients taking confounding medications such as sex steroids, infertility medications or insulin sensitizers or any medication deemed to alter glucose and/or insulin levels
• Active malignancy in the last 5 years
• Patients receiving any other investigational agent(s)
• Ginger and/or aloe allergy

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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