Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Pregnancy.
- •Breastfeeding.
- •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.
研究组 & 干预措施
Combination 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.
干预措施: Combination of Epigallocatechin gallate, vitamin D, vitamin B6, and D-Chiro-inositol (Dietary Supplement)
Placebo
The subject takes the placebo twice a day for three months
干预措施: Placebo (Other)
结局指标
主要结局
Symptoms related to uterine fibromatosis (UFS-QoL questionnaire)
时间窗: 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.
次要结局
- Volume of the larger fibroid(After 3 months of treatment)
- The proportion of patients who refuse surgery due to regression of symptoms.(After 3 months of treatment)
- The total score obtained in the Pad test(After 3 months of treatment)
- Proportion of patients who reported side effects or who stopped taking the treatment(After 3 months of treatment)
- The total score obtained in the Menstrual assessment chart(After 3 months of treatment)
- Quality of life (UFS-QoL questionnaire)(After 3 months of treatment)
研究者
Stefano Uccella
Prof.
Universita di Verona