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

University of Louisville (UOFL)

Status: Withdrawn

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Placebo; Other: Aloe exosomes; Other: Ginger exosomes

Study type: Interventional

Funder types: Other

Identifiers

NCT03493984

17.1114

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Ginger exosomes

Experimental group

Treatment:

Other: Ginger exosomes

Aloe exosomes

Experimental group

Treatment:

Other: Aloe exosomes

Ginger and aloe exosomes

Experimental group

Treatment:

Other: Aloe exosomes

Other: Ginger exosomes

Placebo

Placebo Comparator group

Treatment:

Other: Placebo