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Randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 on symptoms related to uterine fibroids
A randomized controlled trial aimed to evaluate the efficacy of a combination of Epigallocatechin gallate, vitamin D3, D-Chiro-inositol, and vitamin B6 as a treatment for uterine fibroids. The clinical study is double-blind, neither patients nor investigators know whether the subject receives the combination of Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 or the placebo. After 3 months of treatment, changes in symptoms associated with uterine fibroids, quality of life, and ultrasounds characteristics are compared between the two treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol | Experimental | The subject takes a combination of 333.35 mg of green tea extract (150 mg of Epigallocatechin gallate), 25 mg of D-Chiro-inositol, 25 mcg of Vitamin D, and 5 mg of Vitamin B6 twice a day for three months. |
|
| Placebo | Placebo Comparator | The subject takes the placebo twice a day for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol | Dietary Supplement | The subject takes a combination of 333.35 mg of green tea extract (150 mg of Epigallocatechin gallate), 25 mg of D-Chiro-inositol, 25 mcg of Vitamin D, and 5 mg of Vitamin B6 twice a day for three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms related to uterine fibromatosis (UFS-QoL questionnaire) | Symptoms related to uterine fibromatosis assessed with the eight symptom questions of the Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. Score: min 8 - max 40, with higher scores meaning worse outcome. | After 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who refuse surgery due to regression of symptoms. | The proportion of patients who refuse surgery due to regression of symptoms. | After 3 months of treatment |
| Volume of the larger fibroid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Uccella, MD, PhD | AOUI Verona - University of Verona | Principal Investigator |
| Simone Garzon, MD | AOUI Verona - University of Verona | Principal Investigator |
| Pier Carlo Zorzato, MD | AOUI Verona - University of Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUI Verona - University of Verona - Department of Obstetrics and Gynecology | Verona | 37125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23493030 | Background | Baird DD, Hill MC, Schectman JM, Hollis BW. Vitamin d and the risk of uterine fibroids. Epidemiology. 2013 May;24(3):447-53. doi: 10.1097/EDE.0b013e31828acca0. | |
| 23950663 | Background | Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, Al-Hendy A. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013 Aug 7;5:477-86. doi: 10.2147/IJWH.S41021. eCollection 2013. |
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| 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 |
|---|---|
| D014807 | Vitamin D |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Randomized (1:1) double-blind, single-center controlled trial
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|
| Placebo | Other | The subject takes the placebo twice a day for three months. |
|
Volume of the larger fibroid assessed by transvaginal ultrasound
| After 3 months of treatment |
| Quality of life (UFS-QoL questionnaire) | Quality of life assessed with the 29 health-related quality of life questions of the Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire. Score: min 29 - max 145, with higher scores meaning worse outcome. | After 3 months of treatment |
| The total score obtained in the Menstrual assessment chart | The total score obtained in the Menstrual assessment chart. Score: min 0 - N/A max, with higher scores meaning worse outcome. | After 3 months of treatment |
| The total score obtained in the Pad test | The total score obtained in the Pad test. Score: min 0 - N/A max, with higher scores meaning worse outcome. | After 3 months of treatment |
| Proportion of patients who reported side effects or who stopped taking the treatment | Proportion of patients who reported side effects or who stopped taking the treatment | After 3 months of treatment |
| 32271452 | Background | Porcaro G, Santamaria A, Giordano D, Angelozzi P. Vitamin D plus epigallocatechin gallate: a novel promising approach for uterine myomas. Eur Rev Med Pharmacol Sci. 2020 Mar;24(6):3344-3351. doi: 10.26355/eurrev_202003_20702. |
| 19819432 | Background | Zhang D, Al-Hendy M, Richard-Davis G, Montgomery-Rice V, Rajaratnam V, Al-Hendy A. Antiproliferative and proapoptotic effects of epigallocatechin gallate on human leiomyoma cells. Fertil Steril. 2010 Oct;94(5):1887-93. doi: 10.1016/j.fertnstert.2009.08.065. Epub 2009 Oct 12. |
| D010847 |
| Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |