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Completed
NCT05717894
Possibilities of Phytomedicine in Monotherapy of Benign Breast Diseases
Conditions: Fibrocystic Breast Disease
Sex: Female
Ages: 18 Years – 80 Years
Phase: PHASE4
Enrollment: 150
Sponsor: Nazgul Omarbayeva
Location: Kazakhstan
Summary
The aim of this study is to evaluate the effectiveness of the use of the drug, containing Vitex agnus castus extract (VAC), in patients with fibrocystic breast disease .
One hundred fifty women over 40 years old were randomized into patient (n=78) and control (n=72) groups.
The groups were similar regarding age, nulliparity, menopause and abortion status, family history of breast cancer, alcohol consumption, and smoking.
The patient group received two pills containing 200mg of VAC daily for six months, and all participants were evaluated by using a Visual Analogue Scale and ultrasound examination at baseline, 12th and 24th weeks.
Eligibility Criteria
Inclusion Criteria:18 to 80 years oldMust be able to visit the investigators at the appointesssd time.Exclusion Criteria:refused to sign informed consentpregnant and breastfeedinghas severe chronic comorbid diseases (cancer, diabetes mellitus, systemic blood diseases, neuralgia, suffering from mental illness or legally incompetent, e.g.)participated in another clinical trial
Source: ClinicalTrials.gov (NCT05717894). StuddyBuddy aggregates publicly available trial information.
