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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Recruitment Status : Withdrawn (Investigator left the university prior to study approval, no patients enrolled)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
Sponsor:
Information provided by (Responsible Party):
University of Louisville

Tracking Information
First Submitted Date  ICMJE February 20, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date March 16, 2021
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
Official Title  ICMJE 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)
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Other: Ginger exosomes
    Naturally occurring plant exosomes from ginger
  • Other: Aloe exosomes
    Naturally occurring plant exosomes from aloe
  • Other: Placebo
    Exosome placebo tablet
Study Arms  ICMJE
  • Experimental: Ginger exosomes
    Intervention: Other: Ginger exosomes
  • Experimental: Aloe exosomes
    Intervention: Other: Aloe exosomes
  • Experimental: Ginger and aloe exosomes
    Interventions:
    • Other: Ginger exosomes
    • Other: Aloe exosomes
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 12, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2018)
176
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03493984
Other Study ID Numbers  ICMJE 17.1114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry Bohler, MD University of Louisville
PRS Account University of Louisville
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP