This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes t...This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.展开更多
基金Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences:Research Design and Application of Mixed Methods in Traditional Chinese Medicine (No.CI2021B003)Evidence-based Ability Construction Project of National Administration of Traditional Chinese Medicine:Evidencebased Ability Improvement and Platform Construction of Traditional Chinese Medicine in Encephalopathy (No.2019XZZX-NB014)+2 种基金CACMS Innovation Fund:Research Priorities on Screening and Evaluating Appropriate and Effective Health Technologies in Specific Disease Field of TCM (No.CI2021A05503)CACMS Innovation Fund:Evaluation Method and Demonstration Research of Traditional Chinese Medicine Health Technology Assessment (No.CI2021A00701-3)the Fundamental Research Funds for the Central Public Welfare Research Institutes:Evidence Mapping and Scoping Review of Chinese Patent Medicines for Clearing Heat and Detoxifying (No.ZZ13-YQ-075)
文摘This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.
