Randomized, Multicentric Parallel-Group Clinical Trial of the Herbo-Mineral Formulation T-AYU-HM Premium in Patients with Sickle Cell Anemia: A Prospective Study

Background: Sickle Cell Anemia (SCA) is a hereditary blood disorder that significantly impacts the quality of life of those affected. While conventional treatments do have improved patient outcomes, they frequently fall short of managing all the symptoms and complications related to the disease. The trial was supported by established preclinical research, observational case studies and series reports on T-AYU-HM Premium. The present study is randomized, multicentric parallel-group clinical trial of the herbo-mineral formulation T-AYU-HM premium in patients with sickle cell anemia. Materials and Methods: The study was designed as an open-label, randomized, multicentric trial involving 100 sickle cell anemia patients (HbSS). Prior to participation, informed consent was obtained from each patient or their guardian in accordance with the ICH-GCP guideline. Data collection focused on hemoglobin variants, hematological parameters and patients' vital and clinical data, all screened based on specific inclusion and exclusion criteria. The study was conducted over a period of 180 days. The HRQOL-26 assessment tool was employed to assess the effectiveness of the treatment on patients’ quality of life. Results: After 180 days, T-AYU-HM Premium significantly reduced sickle hemoglobin and increased fetal hemoglobin. The formulation also substantially decreased white blood cells, thereby preventing inflammation-associated complications. 93.9% consistently reported experiencing satisfactory sleep and no issues with anxiety, anger, or reduced activity. Additionally, 100% of participants reported no sudden or debilitating pain episodes and remained pain-free during the treatment period with T-AYU-HM Premium. Conclusion: The treatment with T-AYU-HM Premium in sickle cell disease patients demonstrated its effectiveness. Over the 180-day period, no adverse responses were reported, highlighting its safety. Furthermore, the therapy contributed to significant improvements in mental health and pain-related quality of life for the participants.