Integrating traditional ayurvedic medicine into modern HIV/AIDS management: A randomized controlled clinical trial

Abstract

HIV infection remains a major global health challenge. Although antiretroviral therapy (ART) effectively suppresses viral replication, HIV remains incurable because latent, replication-competent proviruses persist in diverse cellular and tissue reservoirs. This study investigated the effect of Yogaraj Rasāyana (YR), a classical Ayurvedic formulation, in augmenting CD4 + T lymphocyte counts in ART-treated HIV-positive individuals. In a randomized controlled trial (RCT), 52 HIV-positive participants (males/females/transgender: 29/20/3) with respective age (mean ± SD: 30.6 ± 7.9, 34.2 ± 10.3 and 32.0 ± 11.1 years), receiving standard ART, were recruited from Patanjali Ayurved Hospital Haridwar, and All India Institute of Medical Sciences Rishikesh, India. Participants were randomized into an Interventional Group (IG; n = 26) receiving YR (2 g/day orally) and ART, and a Conventional Group (CG; n = 26) receiving ART alone for 90 days. Clinical endpoints included CD4+ T cell counts and hematological/biochemical indices (Hemoglobin: Hb, Erythrocyte Sedimentation Rate: ESR, Random Blood Sugar: RBS, Serum Glutamic Oxaloacetic Transaminase: SGOT, Serum Glutamate Pyruvate Transaminase: SGPT, Blood Urea, Serum Creatinine), assessed at baseline and post-intervention. IG demonstrated a statistically significant increase in CD4 + counts and Hb levels (p < 0.05), with no hepatotoxic or nephrotoxic effects. The observed improvements suggest possible immunomodulatory actions of YR, potentially involving enhanced Regulatory T cell (Treg) activity, cytokine balance, and modulation of transcriptional regulators. YR exhibited potential as a safe, affordable adjunct to ART in HIV management. Future studies employing immunophenotyping, cytokine assays, and epigenetic analyses are recommended to elucidate its mechanistic pathways.