Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke: A Double-Blinded, Randomized Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of Tibetan medicine Ruyi Zhenbao Pills(RZPs) in the treatment of patients with motor and sensory dysfunction after stroke. Methods: A total of 120 convalescent stroke patients hospitalized in the Rehabilitation Department of Guangdong Provincial Hospital of Chinese Medicine from June 2017 to December 2019 were enrolled in this trial. Patients were assigned to control(60 cases) and research(60 cases) groups by computer random assignment. All patients received internal treatment and modern rehabilitation training. On this basis, the research group was given oral RZPs for 4 weeks, while the control group was given oral placebo. The primary outcome was motor function of the affected side evaluated by simplified FuglMeyer Motion Assessment Scale(FMA-M). The secondary outcomes included sensory function, activity of daily living(ADL), quality of life, balance function, and pain, which were assessed by Fugl-Meyer Sensory Assessment Scale(FMA-S), Modified Barthel Index(MBI), Special Scale of the Quality of Life(SS-QOL), Berg Balance Scale(BBS), and Visual Analogue Scale(VAS), respectively. All of the assessments were performed before treatment, and 4 and 8 weeks after treatment. Vital signs, liver and kidney functions, routine blood test, blood coagulation profile, and routine urinalysis of patients were monitored. Results: After 4-week treatment, the FMA-M, BBS and FMA-S scores in the research group significantly increased compared with the control group(P<0.05). At 8-week follow-up, the BBS and MBI scores in the research group were higher than the control group(P<0.05). There was no statistical difference between the 2 groups in the SS-QOL and VAS scores at 4 and 8 weeks(P>0.05). Moreover, after treatment, there was no significant difference in vital signs, liver and kidney functions, blood coagulation function, blood routine and urinalysis between the 2 groups(P>0.05). Conclusion: RZPs improved limb motor, balance, and sensory functions of stroke patients during recovery period with good safety.(Trial registration No. NCT04029701)