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This randomised, double-blind, placebo-controlled, multicentre trial investigated whether Yiaikang capsules — a traditional Chinese medicine formula derived from the 1,800-year-old Shuyu pill — could improve outcomes when added to standard antiretroviral therapy in people living with HIV. A total of 144 participants across eight centres were randomly assigned in equal numbers to receive either Yiaikang capsules plus antiretroviral therapy, or a placebo plus antiretroviral therapy, for 48 weeks.
The primary outcome — change in CD4 cell count — strongly favoured the Yiaikang capsule group. At week 48, the adjusted mean CD4 count in the treatment group reached 488.7 cells per cubic millimetre, compared with 385.9 cells per cubic millimetre in the placebo group, a statistically significant difference of 102.8 cells per cubic millimetre. Improvements in traditional Chinese medicine syndrome scores were also evident from week eight onwards. Additionally, Yiaikang capsules significantly reduced levels of immune activation markers and inflammatory proteins including interleukin-4, interferon-gamma, and tumour necrosis factor-alpha. No serious adverse events were reported in either group, suggesting a favourable safety profile.
These findings provide meaningful clinical evidence for the adjunctive role of Yiaikang capsules in HIV management, though longer-term and larger-scale studies would further strengthen confidence in the results.
Conclusion: Yiaikang capsules combined with antiretroviral therapy significantly improved CD4 cell count recovery, reduced immune activation, and alleviated traditional Chinese medicine-defined symptoms in people living with HIV, with no serious safety concerns observed.
Source: Ding X, Meng P, Ma X and colleagues. Journal of ethnopharmacology (2026). View on PubMed (PMID 41967778) · doi:10.1016/j.jep.2026.121641