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The current status of clinical research and reporting of efficacy and safety outcomes of Rannasangpei
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DOI   10.11656/j.issn.1673-9043.2026.09.11
Key Words   rannasangpei;Tibetan medicine;clinical research;disease spectrum;outcome measures
Author NameAffiliationE-mail
SU Youzhu Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China  
LIU Jia Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China  
WANG Mengqi Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China  
WANG Biqing Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China  
LIU Xinyi Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China  
HE Liyun Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China hely3699@163.com 
Abstract
    [Objective] To map the disease distribution and the reporting of efficacy and safety outcomes in clinical studies of Rannasangpei(RNSP),and to inform the direction and design of future clinical research. [Methods] Eight databases were searched from inception to November 2025 for clinical studies of RNSP. Study characteristics,including study design,disease category,and interventions,were summarized descriptively. Efficacy and safety outcomes reported in RNSP monotherapy and add-on studies were further summarized descriptively. [Results] A total of 65 studies were included,comprising 43 parallel-group comparative studies,20 case series,and 2 case reports. All studies were conducted in China and published in Chinese. The included studies covered 19 diseases,predominantly neurological conditions. Stroke was the most frequently investigated condition,accounting for 31 studies(47.69%),and 6 diseases corresponded to indications listed in the package insert. Based on the intervention and comparator designs,24 studies(36.92%) were classified as monotherapy or add-on design studies,including 15 randomized controlled trials(RCTs),4 quasi-randomized controlled trials,and 5 case series,covering 9 diseases. Outcomes reported in the 19 parallel-group studies mainly included categorical clinical response,neurological and motor function,cognitive function,activities of daily living,quality of life,blood pressure,and related biological indicators. The 5 case series mainly reported post-treatment response categories. Five RCTs reported adverse events during treatment,mainly gastrointestinal discomfort,somnolence,fatigue,and mild dizziness,while active adverse-event monitoring and long-term follow-up data were limited. [Conclusion] Clinical research on RNSP has primarily focused on neurological conditions. Nevertheless,opportunities remain to improve study design and reporting,standardize outcome measures,and strengthen long-term safety monitoring. Future research should prioritize disease areas with a relatively established research base and conduct rigorously designed clinical studies to support further evaluation of the efficacy,safety,and clinical utility of RNSP.

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