Résumé
Background: The orphan status of sickle cell invites many researchers toward drug development in the past decade. A substantial number of clinical trials either understudies or in the planning stage focused on sickle cell disease. Sickle cell traits are often considered asymptomatic and the silent condition is associated with diverse complications. Objective: To clinically evaluate the safety and effectiveness of T-AYU-HM Premium Tablets (300mg) in sickle cell anemia patients: an observational retrospective study Methodology: This is a single-arm case-control retrospective study of sickle cell trait patients admitted to Dhanvantari Clinic from 2018 to 2020. Patients' vital and clinical information based on inclusion and exclusion criteria were collected and analyzed using SPSS software. Result: A total of 100 patients with sickle cell traits were included in the study. The treatment exhibited significant improvement was seen in (P<0.05) in hemoglobin and red blood corpuscles. There wasn’t any untoward response either from the patient or from laboratory parameters reported indicating no adverse effects were seen. There was an absolute improvement in overall health as a reduction of no of time hospitalization (0) and blood transfusion (0) in sickle cell trait patients. There was a significant improvement in minor and major clinical parameters of sickle cell trait patients. Conclusion: The effect of T-AYU-HM Premium treatment in sickle cell trait patients suggests it is safe and effective. There was no adverse effect observed in the observational study. During entire study period, no single blood transfusion or hospitalization required. The significant improvement in the rate and frequency of painful crises indicates an improvement in pain-related quality of life in patients. This treatment of T-AYU-HM Premium was safe, cost-effective, and exhibit therapeutic potential in the management of sickle cell trait patients
Résumé
Sickle cell anaemia is a type of haemoglobin disorder causing morbidity and mortality in many countries. The disease is incurable and therefore requires symptomatic management to improve quality of life. Because the alternative system of medicine can play a significant role in the management of quality of life in sickle cell anaemia, lot many combinations and formulations are attempted across many countries. Unfortunately, very few have reached a preclinical and clinical research level. In the current case study, T-AYU-HM Premium was evaluated as per the standard parameters, and a clinical evaluation considering its effect and safety was performed in this case report of a 24-year-old male with a history of sickle cell disease in hereditary. History was 8 times blood transfusion and 7 times hospitalization in past two year. He was infected with covid-19 and hospitalized, recovered with T-AYU-HM Premium only. Next month because of joint pain, fever, and weakness he visited the daycare clinic. On complete physical and laboratory examination he was started on T-AYU-HM Premium 300mg two tablets twice a day. During 6 months of treatment, he had complained of pain only thrice for which analgesics were prescribed, and no blood transfusion was required. During this 6 month period, there is a remarkable improvement in his haemoglobin, red blood corpuscles, white blood cells, and platelets. There were no untoward complaints from him suggesting that T-AYU-HM Premium exhibited its potential in sustaining the cellular integrity and thereby preventing the lysis of red blood corpuscles. The improvement in laboratory parameters, clinical parameters and established studies indicated that T-AYU-HM Premium is safe and exhibit an observational effect on red blood corpuscles of sickle cell anaemia patient.