Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
NCT ID: NCT03493984
Last Updated: 2021-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-10-31
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ginger exosomes
Ginger exosomes
Naturally occurring plant exosomes from ginger
Aloe exosomes
Aloe exosomes
Naturally occurring plant exosomes from aloe
Ginger and aloe exosomes
Ginger exosomes
Naturally occurring plant exosomes from ginger
Aloe exosomes
Naturally occurring plant exosomes from aloe
Placebo
Placebo
Exosome placebo tablet
Interventions
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Ginger exosomes
Naturally occurring plant exosomes from ginger
Aloe exosomes
Naturally occurring plant exosomes from aloe
Placebo
Exosome placebo tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Louisville
OTHER
Responsible Party
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Principal Investigators
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Henry Bohler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville
Louisville, Kentucky, United States
Countries
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Other Identifiers
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17.1114
Identifier Type: -
Identifier Source: org_study_id
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