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Investigator left the university prior to study approval, no patients enrolled
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger exosomes | Experimental |
| |
| Aloe exosomes | Experimental |
| |
| Ginger and aloe exosomes | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger exosomes | Other | Naturally occurring plant exosomes from ginger |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, twelve weeks |
| Serum Testosterone |
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Inclusion Criteria:
Exclusion Criteria:
• Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Henry Bohler, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Aloe exosomes | Other | Naturally occurring plant exosomes from aloe |
|
| Placebo | Other | Exosome placebo tablet |
|
Serum testosterone in ng/dL Changes in serum testosterone as measured in ng/dL |
| Baseline, twelve weeks |
| Sex hormone binding globulin | Changes in sex hormone binding globulin in nmol/L | Baseline, twelve weeks |
| Stool sample | Gut microbiota | Baseline, twelve weeks |
| Inflammatory marker cluster of differentiation 4 (CD4) | CD4 | Baseline, twelve weeks |
| Inflammatory marker cluster of differentiation 8 (CD8) | CD8 | Baseline, twelve weeks |
| Inflammatory marker Foxp3 | Foxp3 | Baseline, twelve weeks |
| Inflammatory marker cluster of differentiation 11b (CD11b) | CD11b | Baseline, twelve weeks |
| Inflammatory marker cluster of differentiation 33 (CD33) | CD33 | Baseline, twelve weeks |
| Inflammatory marker F4/80 | F4/80 | Baseline, twelve weeks |
| Inflammatory marker interleukin 10 (IL-10) | IL-10 | Baseline, twelve weeks |
| Inflammatory marker interleukin 1b (IL-1b) | IL-1b | Baseline, twelve weeks |
| Inflammatory marker tumor necrosis factor alpha (TNF-a) | TNF-a | Baseline, twelve weeks |
| Inflammatory marker interleukin 6 (IL-6) | IL-6 | Baseline, twelve weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |