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

Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01840761
• Other study ID #: 2010B030700029
• Secondary ID: 2010B030700029
• Status: Recruiting
• Phase: Phase 4
• First received: December 12, 2011
• Last updated: April 25, 2013
• Start date: July 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 80 Years

Eligibility

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 ? ~ ?; 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm

Intervention

Drug:
• herbal drug

• placebo

Locations

Country	Name	City	State
China	Guangdong Provincial Science and Technology Agency	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of DCVS after aneurysmal postoperative	after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine	3 months	Yes
Secondary	1 month, 3 month mortality	after 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine	14days,1 month,3 month	Yes

External Links

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