NCT03493984

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

February 20, 2018

Last Update Submit

March 12, 2021

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in glucose tolerance as measured by a glucose tolerance test

    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.

    Baseline, twelve weeks.

Secondary Outcomes (14)

  • Change in serum insulin levels during a glucose tolerance test

    Baseline, twelve weeks

  • Serum Testosterone

    Baseline, twelve weeks

  • Sex hormone binding globulin

    Baseline, twelve weeks

  • Stool sample

    Baseline, twelve weeks

  • Inflammatory marker cluster of differentiation 4 (CD4)

    Baseline, twelve weeks

  • +9 more secondary outcomes

Study Arms (4)

Ginger exosomes

EXPERIMENTAL
Other: Ginger exosomes

Aloe exosomes

EXPERIMENTAL
Other: Aloe exosomes

Ginger and aloe exosomes

EXPERIMENTAL
Other: Ginger exosomesOther: Aloe exosomes

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Ginger exosomesOTHER

Naturally occurring plant exosomes from ginger

Ginger and aloe exosomesGinger exosomes
Aloe exosomesOTHER

Naturally occurring plant exosomes from aloe

Aloe exosomesGinger and aloe exosomes
PlaceboOTHER

Exosome placebo tablet

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Henry Bohler, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

April 11, 2018

Study Start

October 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

US(1)