Leiomyoma, Uterine
Conditions
Keywords
Leiomyoma, Uterine, Epigallocatechin gallate, Vitamin D, D-Chiro-inositol, Vitamin B6
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTCombination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol
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.
OTHERPlacebo
The subject takes the placebo twice a day for three months.
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized (1:1) double-blind, single-center controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for hysterectomy. * Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for myomectomy / uterine arterial embolization. * Women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for treatment with magnetic resonance (MR)-guided Focused Ultra-Sound (MrgFUS).
Exclusion criteria
* Pregnancy. * Breastfeeding. * Smoking. * Suspected malignancy. * Patients who have undergone medical treatment for uterine fibroids within the previous three months. * Patients allergic to the components of the product or placebo under study. * Patients who refuse to provide informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms related to uterine fibromatosis (UFS-QoL questionnaire) | After 3 months of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients who refuse surgery due to regression of symptoms. | After 3 months of treatment | The proportion of patients who refuse surgery due to regression of symptoms. |
| Volume of the larger fibroid | After 3 months of treatment | Volume of the larger fibroid assessed by transvaginal ultrasound |
| Quality of life (UFS-QoL questionnaire) | After 3 months of treatment | 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. |
| The total score obtained in the Menstrual assessment chart | After 3 months of treatment | The total score obtained in the Menstrual assessment chart. Score: min 0 - N/A max, with higher scores meaning worse outcome. |
| The total score obtained in the Pad test | After 3 months of treatment | The total score obtained in the Pad test. Score: min 0 - N/A max, with higher scores meaning worse outcome. |
| Proportion of patients who reported side effects or who stopped taking the treatment | After 3 months of treatment | Proportion of patients who reported side effects or who stopped taking the treatment |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORStefano Uccella, MD, PhD
AOUI Verona - University of Verona
PRINCIPAL_INVESTIGATORSimone Garzon, MD
AOUI Verona - University of Verona
PRINCIPAL_INVESTIGATORPier Carlo Zorzato, MD
AOUI Verona - University of Verona
Outcome results
None listed