Clinical Evaluation of T-AYU-HM Premium in Sickle Cell Disease (HbSS) Patients: A Retrospective Study

Abstract

Background: Sickle cell disease (HbSS) is one of the main hemoglobinopathies that affect the indigenous tribes and is a significant cause of morbidity and mortality. The effectiveness and safety of alternative medicines for sickle cell disease patients require further scientific study. The proposed study was conducted to clinically evaluate the safety and effectiveness of T-AYU-HM Premium Tablet (300 mg).Materials and Methods: This is a single-arm observational retrospective cohort study of 100 sickle cell disease subjects. Based on inclusion and exclusion criteria, the clinical and vital information of the patients was acquired, assessed, and reported. A follow-up period of 120±10 days was deemed sufficient. Data were analysed using a statistical package for the social sciences (SPSS).Results: The levels of haemoglobin (g/dL) (9.43±1.83 to 10.11±1.37) and red blood cells (/mm3) (3.89±0.81 to 4.18±0.64) were significantly improved (p<0.05). Reticulocyte count (%) changed significantly from 4.51±3.20 to 2.84±2.34. The number of blood transfusions (7.12±26.80 to 00) and the percentage of hospitalisations (76% to 00) that occurred more than six times prior to presentation were significantly reduced.Conclusion: In this retrospective analysis, there were no reported adverse consequences. Patient’s responses and all the clinical parameters like haematology, liver function parameters, clinical, and pain-associated symptoms with the disorder showed T-AYU-HM Premium to be an effective and safer therapy in the treatment of sickle cell anemia. Further well-planned interventional studies may become useful to justify the same.

Keywords: Sickle cell disease (HbSS); Haemoglobin; Reticulocytes