Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
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ClinicalTrials.gov Identifier: NCT03493984 |
Recruitment Status :
Withdrawn
(Investigator left the university prior to study approval, no patients enrolled)
First Posted : April 11, 2018
Last Update Posted : March 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome | Other: Ginger exosomes Other: Aloe exosomes Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Mitigate Insulin Resistance and Chronic Inflammation in Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) |
Estimated Study Start Date : | October 2019 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | May 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Ginger exosomes |
Other: Ginger exosomes
Naturally occurring plant exosomes from ginger |
Experimental: Aloe exosomes |
Other: Aloe exosomes
Naturally occurring plant exosomes from aloe |
Experimental: Ginger and aloe exosomes |
Other: Ginger exosomes
Naturally occurring plant exosomes from ginger Other: Aloe exosomes Naturally occurring plant exosomes from aloe |
Placebo Comparator: Placebo |
Other: Placebo
Exosome placebo tablet |
- Change in glucose tolerance as measured by a glucose tolerance test [ Time Frame: Baseline, twelve weeks. ]A glucose challenge test will be administered after initially obtaining a fasting serum glucose(baseline), then administering a 75 gram glucose load orally, then a serum glucose will be obtained 2 hours later. Serum glucose is measured in mg/dL.
- Change in serum insulin levels during a glucose tolerance test [ Time Frame: Baseline, twelve weeks ]Serum insulin levels in multi-international units per litre (mIU/L) will be measured at baseline and after 2 hours during a 2-hour glucose tolerance test
- Serum Testosterone [ Time Frame: Baseline, twelve weeks ]Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL
- Sex hormone binding globulin [ Time Frame: Baseline, twelve weeks ]Changes in sex hormone binding globulin in nmol/L
- Stool sample [ Time Frame: Baseline, twelve weeks ]Gut microbiota
- Inflammatory marker cluster of differentiation 4 (CD4) [ Time Frame: Baseline, twelve weeks ]CD4
- Inflammatory marker cluster of differentiation 8 (CD8) [ Time Frame: Baseline, twelve weeks ]CD8
- Inflammatory marker Foxp3 [ Time Frame: Baseline, twelve weeks ]Foxp3
- Inflammatory marker cluster of differentiation 11b (CD11b) [ Time Frame: Baseline, twelve weeks ]CD11b
- Inflammatory marker cluster of differentiation 33 (CD33) [ Time Frame: Baseline, twelve weeks ]CD33
- Inflammatory marker F4/80 [ Time Frame: Baseline, twelve weeks ]F4/80
- Inflammatory marker interleukin 10 (IL-10) [ Time Frame: Baseline, twelve weeks ]IL-10
- Inflammatory marker interleukin 1b (IL-1b) [ Time Frame: Baseline, twelve weeks ]IL-1b
- Inflammatory marker tumor necrosis factor alpha (TNF-a) [ Time Frame: Baseline, twelve weeks ]TNF-a
- Inflammatory marker interleukin 6 (IL-6) [ Time Frame: Baseline, twelve weeks ]IL-6

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
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:
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• 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493984
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Henry Bohler, MD | University of Louisville |
Responsible Party: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT03493984 |
Other Study ID Numbers: |
17.1114 |
First Posted: | April 11, 2018 Key Record Dates |
Last Update Posted: | March 16, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |