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Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine

Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01840761
Enrollment
60
Registered
2013-04-26
Start date
2010-07-31
Completion date
2015-12-31
Last updated
2013-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm

Keywords

delayed vasospasm,, medicine,, standardization

Brief summary

Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is no standard clinical treatment programs, limiting the advantages and characteristics of traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80 times craniotomies and surgical interventions , with a rich source of patiengs to carry out the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang syndrome and comprehensive treatment programe of the State 1995,the 15th research , in accordance with characteristics of the pathophysiology and understanding of cause and pathogenesis in aSAH perioperative period , through expert advice and review of the literature, under the guidance of Liu Maocai who isChinese medicine practitioners of Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other aspects of efficacy evaluation, developmenting a standardized treatment program of delayed CVS after aSAH . To evaluate the efficacy of the standardized program by prospective, randomized,controlled clinical trial,improving the postoperative results, reducting significantly the mortality and morbidity patients with cerebral aneurysms.

Interventions

DRUGplacebo

Sponsors

Guangzhou University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Between the ages of 14-80 years old patients; * Comply with the diagnostic criteria for Chinese and Western medicine; * Comply with embolization of intracranial aneurysms or cranial aneurysm surgery indications; * Preoperative Hunt and Hess grade of Ⅰ \ Ⅳ; The first disease or previous history of stroke but no sequelae; * Acceptance within 72h onset cranial aneurysm embolization or craniotomy aneurysm surgeon; * Informed consent;

Exclusion criteria

* The age of 14 years of age or in patients over 80 years of age; * By hypertension, a variety of blood diseases, amyloid angiopathy, cerebral arteritis, cerebral abnormal vascular network (moyamoya disease), brain tumor brain metastases as a result of bleeding; * Associated with cardiovascular, liver and kidney and hematopoietic system of primary disease, mental illness; * 72h of onset did not receive cranial aneurysm embolization or craniotomy for aneurysm surgery were;

Design outcomes

Primary

MeasureTime frameDescription
The incidence of DCVS after aneurysmal postoperative3 monthsafter 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine

Secondary

MeasureTime frameDescription
1 month, 3 month mortality14days,1 month,3 monthafter 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026