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

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Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

Abstract

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 Fugl-Meyer 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)

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Acknowledgement

We sincerely thank for the consent of all patients and their families. We also thank for the help of blinding from Methodological Team in Guangdong Provincial Hospital of Chinese Medicine.

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Authors and Affiliations

  1. Department of Rehabilitation, The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, 510120, China

    Shan-shan Ling, Rui-huan Pan, Le-chang Zhan, Mei Li, Zhi-jing Yang & Hong-xia Chen

  2. The Second Institute of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510120, China

    Hao-dong Yang

Authors
  1. Shan-shan Ling
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  2. Rui-huan Pan
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  3. Le-chang Zhan
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  4. Mei Li
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  6. Hao-dong Yang
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  7. Hong-xia Chen
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Contributions

Ling SS and Pan RH designed this study and wrote the draft. Chen HX conceived this study and revised the manuscript. Zhan LC helped with the operation training, including drugs distribution and assessment test. Li M was responsible for cases inclusion and randomization. Yang ZJ and Zhan LC helped with the data analysis. Yang HD and Ling SS registered and submitted this trial to ClinicalTrials.gov. All authors have read and approved the final version of this paper.

Corresponding author

Correspondence to Hong-xia Chen.

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Conflict of Interest

The authors declare no conflict of interest of publication or others.

Supported by SHEN Bao-fan Academic Experience Inheritance Studio of Guangdong Provincial Hospital of Chinese Medicine

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Ling, Ss., Pan, Rh., Zhan, Lc. et al. Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke: A Double-Blinded, Randomized Placebo-Controlled Clinical Trial. Chin. J. Integr. Med. 28, 872–878 (2022). https://doi.org/10.1007/s11655-022-3577-9

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  • DOI: https://doi.org/10.1007/s11655-022-3577-9

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