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The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.
The patients will be evaluated at baseline and after three months of treatment with placebo or product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGCG, Vit D, DCI, Vit B6 | Active Comparator | Women with uterine fibroids randomized to treatment group |
|
| Placebo | Placebo Comparator | Women with uterine fibroids randomized to placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol | Dietary Supplement | The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D |
| Measure | Description | Time Frame |
|---|---|---|
| Diameter | Greater diameter of the diagnosed uterine fibroids | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Volume | Total volume of the diagnosed uterine fibroids | 3 months |
| Need for surgery | The percentage of patients that decide to avoid surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo Stomati, Ph. D | Contact | 0831851303 | mstomati@gmail.com | |
| Andrea Tinelli, Ph. D | Contact | 0832394507 | andreatinelli@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Dario camberlingo | Recruiting | Francavilla Fontana | Apulia | 72021 | Italy |
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Women with uterine fibroids
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The study will be a double-clind, placebp-controlled trial
| Placebo | Dietary Supplement | Maltodextrines |
|
| 3 months |
| pVEGF-R | the phosphorilation of VEGF receptor | 3 months |
| Marker of cellular proliferation | expression of ki67, ER, PR | 3 months |
| Ospedale Veris Delli Ponti | Not yet recruiting | Scorrano | Apulia | 73020 | Italy |
|
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| D014807 | Vitamin D |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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