Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

Lo.Li.Pharma

Status: Enrolling

Conditions: D-chiro-inositol; Epigallocatechin Gallate; Uterine Fibroids; Inositol; Vitamin D; Vitamin B6

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

Study type: Interventional

Funder types: Industry

Identifiers

NCT05448365

DELPHYS PLUS

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 30 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
2. eligible for surgery
3. symptoms like menometrorrhagia or pelvic pain

Exclusion criteria

1. BMI>30
2. currently pregnant or breastfeeding
3. diabetic
4. suspect of malignancy
5. diagnosis of cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

EGCG, Vit D, DCI, Vit B6

Active Comparator group

Description:

Women with uterine fibroids randomized to treatment group

Treatment:

Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

Placebo

Placebo Comparator group

Description:

Women with uterine fibroids randomized to placebo group

Treatment:

Dietary Supplement: Placebo