Combined Ruyi Zhenbao Pills-Baimai Ointment Therapy on Acute Ischemic Stroke: A Multi-Arm, Randomized, Double-Blind, Placebo Controlled Clinical Study.

Abstract

Background: Ruyi Zhenbao Pills (RZPs) and Baimai Ointment (BMO), prescribed Tibetan formulations, have been confirmed as having a neuroprotective role in animal and cell models of stroke. However, the effects of RZPs and BMO in individuals with acute ischemic stroke (AIS) remain unclear. This is the first multicenter, large-sample, controlled trial to evaluate the therapeutic potential of traditional Tibetan medicine-specifically the RZP and BMO-in the treatment of AIS, thereby extending ethno-pharmacological evidence into modern stroke care.

Methods: A multi-arm, randomized, double-blind, placebo controlled clinical trial was conducted at 21 hospitals in China between December 2020 and September 2022. The inclusion criteria are as follows: individuals diagnosed as AIS, 18 to 75 years of age and within 14 days of AIS onset. Subjects were randomly assigned in a 1:1:1:1 ratio to RZPs+BMO, RZPs, BMO, or placebo. The primary outcome was change of Fugl-Meyer assessment (FMA) score from baseline to day 90.

Results: Four hundred and twenty-three participants were recruited and randomly allocated to the RZPs+BMO group (n=108), RZPs group (n=108), BMO group (n=99), or placebo group (n=108). The change from baseline to D90 in FMA score was 31.22 (SD 16.64) with RZPs+BMO, 29.25 (15.92) with RZPs, 29.88 (15.42) with BMO, and 19.20 (14.38) with placebo (RZPs+BMO group versus placebo group, P< 0.001).

Conclusion: Among Chinese patients suffering from AIS, combined RZPs and BMO therapy improved significantly the primary outcome of 90-day motor functions compared with placebo with acceptable safety, indicating that RZPs and BMO might be an effective therapeutic strategy in patients with AIS.