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

NCT ID: NCT01840761

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

herbal drug

Traditional Chinese herbal drug

Group Type: EXPERIMENTAL

herbal drug

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

herbal drug

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial Science and Technology Agency

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

jianwen Guo, dr.

Role: primary

jianwen_guo@msn.com

020-81887233 ext. 34530

Related Links

http://www.gdhtcm.com

Related Info

Other Identifiers

2010B030700029

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010B030700029

Identifier Type: -

Identifier Source: org_study_id