CLINICAL EVALUATION OF SOWA-RIGPA FORMULATION SEDU-4 & DADUD-7 IN THE MANAGEMENT OF SKA-RBAB (IRON DEFICIENCY ANEMIA): A STRATIFIED RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Iron Deficiency Anemia (IDA) is a global health challenge often complicated by the side effects of conventional iron salts. Sowa Rigpa (Traditional Himalayan Medicine) offers formulations like Sedu-4 and Dadud-7, which target digestive heat (me-dro) and hematopoiesis, yet clinical validation remains limited. Objective: To evaluate the efficacy and safety of Sowa Rigpa formulations Sedu-4 (S4) and Dadud-7 (D7) in improving hemoglobin (Hb) levels and clinical symptoms in patients with IDA. Materials and Methods: 1.Trial Design: An open-label, four-arm randomized controlled trial. 2.Settings: Two centers in India (Sarnath, Varanasi and Choglamsar, Leh). 3.Participants: 115 participants (aged 18–50) with diagnosed IDA were enrolled. 4.Interventions: Participants were randomized into four groups: (A) Sedu-4 (3.42g BID), (B) Dadud-7 (1.69g OD), (C) Combination (S4+D7), and (D) Control (No intervention). The treatment duration was 12 weeks. 5.Outcomes: The primary outcome was the change in mean Hemoglobin (Hb g/dL). Secondary outcomes included clinical symptom scores (fatigue, pallor) and safety parameters. Results: A total of 115 participants were analyzed. The Sedu-4 group showed a statistically significant increase in mean Hb from 10.6±0.9 g/dL to 12.4±1.1 g/dL (p<0.05). The Dadud-7 group remained stable (9.9±1.4 to 10.1±1.7g/dL; p=0.645) but showed the highest improvement in functional fatigue scores. The Control group showed a significant physiological decline in Hb levels (13.0±0.7 to 12.4±1.6 g/dL; p=0.033). No serious adverse events were reported in any intervention group. Conclusion: Sedu-4 is an effective erythropoietic agent for IDA, while Dadud-7 provides significant symptomatic and functional relief. These findings support the integration of Sowa Rigpa formulations as viable, safe alternatives for managing anemia.