Open Label, Single Centre Study of Babao Relief Capsule as an Adjuvant to HAART in Antiretroviral Naive HIV Patients

Abstract

HIV continues to be a major global public health issue, having claimed 36.3 million [27.2–47.8 million] lives so far (WHO, 2021). Sub-Sahara Africa remains the far worst affected region, with 20.6 million [16.8 million– 24.4 million] people living with HIV at the end of 2010, compared to 24.4 (22.5-27.3 million) in 2020. Complementary and alternative therapy (CAM) has been used to treat HIV patients by clinicians in conventional health services in combination with highly active antiretroviral therapy (HAART). To determine efficacy of Babao relief capsule when used as an adjuvant to standard HAART in antiretroviral naïve HIV patients. The product is a biological Chinese medicinal preparation, made of herbs. Ingredients include ginseng, beer antler, musk, bezoar, fleeceflower, Chinese angelica, lyceum, pericarpium citri reticulatae, safflower and ophiopogn japonicus. Open Label Phase 1 bridging Clinical trial to study the efficacy of Babao relief capsule when used in combination standard HAART in antiretroviral naïve HIV patients. A total of one hundred and ninety-six (196) adult patients attending the HIV clinic were randomly selected. The interventional group was on Babao relief capsule and HAART while the control group was on HAART only. The study shows general efficacy of the standard HAART drugs. However, the interventional arm showed a significant increase in the CD4 cell count, showing that BRC had booster effects in the efficacy of HAART. Keywords: HIV, Complementary and alternative therapy, Babao relief capsule, standard highly active antiretroviral therapy.