Efficacy of Gandhakadi Yoga and Sharapunkha Vati as an add on to standard-of-care in the management of thalassemia major (Beejadushtijanya Pandu) in children – A randomized controlled clinical trial

Introduction: Thalassemia major (TM) is a severe form of beta thalassemia, a malignant genetic disorder causing iron overload due to frequent blood transfusions. Gandhakadi Yoga (GY) has been proved effective against iron overload in experimental studies and clinical study, Sharapunkha is indicated as Yakritashothaghna (hepatoprotective), Pleehashothaghana (spleenoprotective), Jwaraghna (anti pyretic), and Vishaghna (anti poison) activity in Ayurveda, and is used in clinical practices since long. Hence, these both drugs were taken for clinical evaluation. Aim: The aim of this study is to evaluate the efficacy of GY and Sharapunkha Vati (SV) as an add-on to standard-of-care (SOC) in the management of TM ( Beejadushtijanya Pandu ) in children. Materials and Methods: A total of 50 patients of age group 2–12 years were registered and randomly divided into two groups: Group A (trial group) GY with SV as an add on to SOC and Group B (control group) in which SOC was given to the registered participants. The assessment was done based on the parameters such as Panduta (pallor), Hriddravatva (palpitation), Daurbalya (weakness), Akshikutashotha (periorbital puffiness), Jwara (fever), Aruchi (anorexia), Udarashula (abdominal pain), Pleehavriddhi (splenomegaly), Yakritavriddhi (hepatomegaly), Atisara (diarrhea), Pindikodweshtana (leg cramps) Sandhishoola (arthralgia), blood transfusion interval, complete blood count, liver function test; serum creatinine, and anemia markers such as serum iron, serum total iron-binding capacity, and serum ferritin) after 12 weeks of treatment. Results: Out of 50 enrolled patients, 46 patients completed treatment. Trial drug provided statistically significant reduction in the pallor ( P < 0.001) , weakness ( P < 0.001) , periorbital puffiness ( P < 0.001) , fever ( P < 0.001) , anorexia ( P < 0.001) , leg cramps ( P = 0.002), abdominal pain ( P = 0.020), and hepatomegaly ( P = 0.014) and blood transfusion interval was prolonged by 6 days. In comparison between both groups, significant difference was found in pallor ( P < 0.001), weakness ( P = 0.01), periorbital puffiness ( P < 0.001), fever ( P = 0.002) anorexia ( P < 0.001), leg cramps ( P < 0.001), abdominal pain ( P = 0.011), hepatomegaly ( P = 0.005), diarrhea ( P = 0.014), mean corpuscular hemoglobin ( P = 0.040), and mean corpuscular hemoglobin concentration ( P = 0.026). Conclusion: GY with SV as add on to SOC provided better results than SOC alone. Mean blood transfusion interval was also increased by 6 days in the interventional group. Hence, it can be concluded that Ayurveda intervention has an effective role as an adjuvant in the management of TM.