Efficacy and Safety of the Two Ayurveda Drug Regimens in Uterine Fibroids: A Randomized Single-Blind Clinical Trial

Abstract

(is study aims to assess the e and safety of two Ayurveda drug regimens for the treatment of uterine -broids (UF) in a randomized single-blind clinical trial. 120 participants with UF (volume≥2 cm3) were randomly allocated at a 1 :1 :1 ratio to 2 experimental groups and the control group. (e 12-week intervention period was followed by 12-week follow-up. (e primary e+cacy endpoint was the change of the largest UF volume. (e secondary e+cacy endpoints were assessed by the pictorial bleeding assessment score (PBAC), UF symptoms, and quality of life score. (e safety endpoints were changed in hepatic and renal safety parameters and patients experiencing adverse e7ects. Signi-cant decrease was observed in the volume of UF in the arm II but not in arm I, while a signi-cant increase was observed in the volume of the largest UF in the control group at 12th week. (e PBAC score remained stable in all groups. Further mean value of the intervention arms symptom severity subscale (SSS) was signi-cantly reduced compared to the control arm. Health-related quality of life (HRQL) value improved in 12th week of both experimental arms compared to baseline. Control arm HRQL value was reduced compared to baseline. (e volume of the largest UF and both SSS and HRQL values remained stable within the follow-up period in the tested arms. (e -ndings of this study demonstrated the safety and e+cacy of selected two Ayurveda drug regimens in reducing the volume of UF and related symptoms and improving quality of life.