Efficacy of two Ayurveda Drug Regimens for Uterine Fibroids, a Randomized, Single Blind, Three-Arm, Clinical Trial- Study Protocol

Abstract

Uterine fibroids are the most common genital tract tumor in reproductive age women. The main treatment option for fibroid is surgical intervention. Options for medical therapy are currently limited to preoperative reduction of symptoms related to uterine bleeding and fibroid size. Ayurveda treatment for this condition is widely practiced in Sri Lanka. We aimed to evaluate the efficacy of two Ayurveda treatment regimes in patients with uterine fibroids. The study is designed as a randomized, single blind, three arm clinical study with 30 participants in each arm. Participants diagnosed with uterine fibroids size 2 cm or more and meet the inclusion criteria are enrolled to this study. Arm I and Arm II undergo two Ayurveda treatment regimens and Arm III is the control group. Endpoint will be calculated from baseline in volume of the largest fibroid by two dimension ultrasound scan after 12 weeks of treatment intervention and repeat in four weeks follow up. Clinical improvements and quality of life is assessed by Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL). Effect of therapy on each arm is assessed based on the Ayurveda body constitution (Prakriti). Haematological investigations are conducted before and after the treatment as safety parameters. Statistical analysis will be done using SPSS version 16. All statistical tests will be performed, two-tailed with significance determined by reference to the 5% level. Outcome of this study will be to developed evidence-based effective alternative to standard methods of treating uterine fibroids