None listed
Conditions
Interventions
Dietary Supplement : Each tablet of Myostat Plus® contains 330 mg of green tea extract powder (including 150 mg of EGCG), 25 µg (1,000 IU) of vitamin D3 (cholecalciferol), and 5 mg of vitamin B6 (pyri
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Adult women aged 19 years or older at the time of informed consent. 2) Women who have been confirmed and diagnosed with uterine fibroids at the study site prior to the baseline visit (Visit 1) by transvaginal ultrasound, abdominal ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT). 3) Women with at least one measurable, non-calcified uterine fibroid confirmed by transvaginal ultrasound, with a maximum diameter of =3 cm or a volume of =2 cm³. 4) Premenopausal women aged 60 years or younger* *Defined as having experienced at least one menstrual period within three months prior to the baseline visit (Visit 1). 5) Women who have received a detailed explanation of the study, fully understood it, voluntarily decided to participate, and provided written informed consent to comply with the precautions and requirements described in the protocol.
Exclusion criteria
Exclusion criteria: 1) Individuals with hypersensitivity to the main ingredients of the investigational food product (Vitamin D, Vitamin B6, EGCG) or to any excipients/additives. 2) Individuals who have taken high-dose Vitamin D (more than 400 IU), Vitamin B6, or EGCG within 4 weeks prior to the baseline visit (Visit 1), or are expected to take them during the study period. 3) Individuals with a history of severe hypersensitivity or allergy to sanitary products such as sanitary pads. 4) Individuals with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 5) Individuals with hypercalcemia. 6) Individuals with kidney stones, moderate to severe renal impairment, end-stage renal disease (ESRD), or those undergoing dialysis. 7) Individuals who have liver cirrhosis, hepatic failure, or chronic active viral hepatitis at the baseline visit (Visit 1), or who have clinically significant abnormal liver function test results. 8) Individuals with a history of alcohol or drug abuse. 9) Individuals who are malnourished, in a debilitated state, or judged by the investigator to engage in persistent excessive alcohol consumption. 10) Individuals diagnosed with acquired immunodeficiency syndrome (AIDS) or currently receiving anti-HIV medications (e.g., atazanavir, rilpivirine). 11) Individuals who participated in another human study or clinical trial and received an investigational food product or investigational drug within 12 weeks prior to the start of administration of this investigational food product, or who are participating in another trial at the time of the baseline visit. 12) Individuals with severe infections or severe trauma. 13) Women who are pregnant or breastfeeding, or planning to become pregnant and/or breastfeed during the planned study period. 14) Women who do not agree to use two medically accepted methods of contraception (e.g., barrier methods [male condom, female condom, or pessary with spermicide], hormonal contraception [implant, injection, combined oral contraceptives, transdermal patch, or vaginal ring], or intrauterine device) during the planned study period and for 14 days after the end of administration of the investigational food product. (However, women who are surgically sterile [e.g., bilateral oophorectomy and thus cannot become pregnant may participate without contraception agreement.) 15) Individuals deemed unsuitable for participation in this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the volume of the largest fibroid;Change in menstrual blood loss(Pictorial bleeding assessment chart , PBAC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Uterine fibroid symptom (UFS) severity and quality of life (QoL) assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactInhye Shin
The Catholic University of Korea, Yeouido St. Mary's Hospital
Outcome results
None listed