Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202833
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-12-03
Brief Title:
Tongyuan Acupuncture on Consciousness Disorder After Stroke
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Study on the Effect of Tongyuan Acupuncture on Consciousness Disorder After Stroke
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAOCDAS
Brief Summary:
Stroke is a common and frequently-occurring disease in the world Patients with stroke often have sequelae and functional disorders of varying degrees among which the disturbance of consciousness has the greatest impact on prognosis and quality of lifeAt present drug therapy neurosurgical interventional therapy and modern physical therapy are mainly used for post-stroke consciousness disorders The above therapies to improve the state of consciousness of patients are not supported by sufficient evidence-based evidence and the other is that they have shortcomings such as invasive expensive and strict indications Acupuncture has been used in the treatment of sequelae of stroke for thousands of years in China Tongyuan acupuncture is a set of traditional Chinese medicine therapy pioneered by Professor Lai Xinsheng a famous doctor of Chinese medicine A large number of previous studies have proved that Tongyuan acupuncture has a unique effect on the cardiovascular system gynecology ent neurology and other functional disorders In this study Tongyuan acupuncture was used in patients with post-stroke consciousness disorder to observe its efficacy and explore the mechanism of action The purpose of this study is to investigate whether Tongyuan acupuncture can improve the consciousness disorder after stroke and to provide a new safe effective feasible and easy to popularize treatment method
Detailed Description:
This study was a randomized placebo-controlled single-blind study Approximately 174 people will participate in the study at the medical facility Patients with post-stroke consciousness disorder hospitalized in the Rehabilitation Department of Nanfang Hospital Guangzhou China were randomly included into the experimental group and the control group and the experimental group was treated with Tongyuan needle acupuncture on the basis of routine rehabilitation therapy and drug therapy Experimental group selected points baihui zhongwan guanyuan qihai tianshu doubleThe control group was treated with 1cm acupuncture at the same depth beside the selected points of the experimental group Before intervention treatment for 1 week treatment for 2 weeks treatment for 3 weeks and treatment for 4 weeks after completion follow-up Glasgow coma score Modified Coma Recovery ScaleCRS-R scale were performed 4 weeks after discharge to assess the conscious state of the patients and electroencephalogramEEG brainstem evoked potential and Encephalofluctuography were examined before intervention and 4 weeks after treatment The baseline data of the experimental group and the control group showed no statistical difference through statistical analysis Conventional rehabilitation treatment and drug treatment were adopted by the current guidelines and the distribution of cases in the two groups was also random
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None