Randomized, Single Blind, Standard Controlled, Equivalence Clinical Trial to Evaluate the Comparative Efficacy of Eladi Kasaya Versus Tranexamic Acid Tablet in the Management of Asrigdara (Heavy Menstrual Bleeding): A Clinical Trial Protocol

Abstract

Introduction: Excessive menstrual bleeding is a common problem in reproductive age group females, and it is reported that 1 in 20 lifetime chances, a female needs consulting the physician for excessive and prolonged menstrual bleeding. Ayurvedic literature describes excessive menstrual bleeding as Asrigdara (HMB). Eladi kasaya is one of the treatment modalities for heavy menstrual bleeding given in classics and hence chosen for the current clinical trial. Methods: We planned a prospective, randomized, controlled, and equivalence trial on the patients with Heavy menstrual bleeding (blood loss > 80 ml) for the last two cycles or more. Eladi Kasaya 50 ml with honey and sharkara(sugar) thrice a day will be given from day 1 to day 7 for 3 consecutive menstrual cycles to Group A and Tablet Tranexamic acid 500mg thrice a day to Group B. Primary outcome measures are menstrual blood loss improvement, reduction in pain assessed by visual analog scale, and change in Haemoglobin concentration. The secondary outcome measure is improvement in quality of life. All adverse drug reactions will be monitored and reported to Ayush Suraksha, pharmacovigilance center, Maharashtra.  Following sample size calculation 46 patients will be recruited in each group to demonstrate equivalence with 80% power. The duration of study will be 2 years. The study is approved through Institutional Ethics Committee dated 07/10/2022, MGACHRC/IEC/Oct-2022/585. Participant recruitment shall be started after getting registered with the Clinical Trial Registry of India. Results: Current manuscript is a clinical protocol, hence results are yet to derive from the study. Results will be presented in conferences and shall be attempted to publish in indexed/peer-reviewed medical journals. Conclusion: Conclusion shall be drawn after completion of the clinical study.