Polycystic Ovary SyndromeNCT03493984
Plant Exosomes and Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) 17
A study testing Ginger exosomes and Aloe exosomes in people with Polycystic Ovary Syndrome, run by University of Louisville at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Ginger exosomes and Aloe exosomes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
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)
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
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Ginger exosomes, Aloe exosomes, Placebo
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger exosomesOther
Naturally occurring plant exosomes from ginger
Aloe exosomesOther
Naturally occurring plant exosomes from aloe
PlaceboOther
Exosome placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Ginger exosomes | Experimental | Not described Receives: Other: Ginger exosomes |
| Aloe exosomes | Experimental | Not described Receives: Other: Aloe exosomes |
| Ginger and aloe exosomes | Experimental | Not described Receives: Other: Ginger exosomes; Other: Aloe exosomes |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, twelve weeks.
Secondary outcomes (14)
Change in serum insulin levels during a glucose tolerance test
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
Measured: Baseline, twelve weeks
Serum Testosterone
Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL
Measured: Baseline, twelve weeks
Sex hormone binding globulin
Changes in sex hormone binding globulin in nmol/L
Measured: Baseline, twelve weeks
Stool sample
Gut microbiota
Measured: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 4 (CD4)
CD4
Measured: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 8 (CD8)
CD8
Measured: Baseline, twelve weeks
Inflammatory marker Foxp3
Foxp3
Measured: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 11b (CD11b)
CD11b
Measured: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 33 (CD33)
CD33
Measured: Baseline, twelve weeks
Inflammatory marker F4/80
F4/80
Measured: Baseline, twelve weeks
Inflammatory marker interleukin 10 (IL-10)
IL-10
Measured: Baseline, twelve weeks
Inflammatory marker interleukin 1b (IL-1b)
IL-1b
Measured: Baseline, twelve weeks
Inflammatory marker tumor necrosis factor alpha (TNF-a)
TNF-a
Measured: Baseline, twelve weeks
Inflammatory marker interleukin 6 (IL-6)
IL-6
Measured: Baseline, twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study startOct 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Investigator left the university prior to study approval, no patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry Bohler, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493984
- Sponsor's protocol ID
- 17.1114
- Status last verified
- Mar 2021
- First submitted
- 20 Feb 2018
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03493984
- Acronym / sponsor ID
- 17.1114
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the university prior to study approval, no patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ginger exosomes | Experimental | Other: Ginger exosomes |
| Aloe exosomes | Experimental | Other: Aloe exosomes |
| Ginger and aloe exosomes | Experimental | Other: Ginger exosomes, Other: Aloe exosomes |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- • Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger exosomesNaturally occurring plant exosomes from ginger | Other | Ginger and aloe exosomes, Ginger exosomes |
| Aloe exosomesNaturally occurring plant exosomes from aloe | Other | Aloe exosomes, Ginger and aloe exosomes |
| PlaceboExosome placebo tablet | Other | Placebo |
Primary outcome
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.
14 secondary outcomes
Change in serum insulin levels during a glucose tolerance test
Time frame: Baseline, twelve weeks
Serum Testosterone
Time frame: Baseline, twelve weeks
Sex hormone binding globulin
Time frame: Baseline, twelve weeks
Stool sample
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 4 (CD4)
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 8 (CD8)
Time frame: Baseline, twelve weeks
Inflammatory marker Foxp3
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 11b (CD11b)
Time frame: Baseline, twelve weeks
Inflammatory marker cluster of differentiation 33 (CD33)
Time frame: Baseline, twelve weeks
Inflammatory marker F4/80
Time frame: Baseline, twelve weeks
Inflammatory marker interleukin 10 (IL-10)
Time frame: Baseline, twelve weeks
Inflammatory marker interleukin 1b (IL-1b)
Time frame: Baseline, twelve weeks
Inflammatory marker tumor necrosis factor alpha (TNF-a)
Time frame: Baseline, twelve weeks
Inflammatory marker interleukin 6 (IL-6)
Time frame: Baseline, twelve weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Bohler, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger exosomes and Aloe exosomes in people with Polycystic Ovary Syndrome, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance as measured by a glucose tolerance test (time frame: Baseline, twelve weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.