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

NCT01840761 | Unknown Phase 4 DMC

• 1 other identifier: 2010B030700029
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

delayed vasospasm,; medicine,; standardization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 1 month, 3 month mortality

  14days,1 month,3 month

Study Arms (2)

herbal drug

EXPERIMENTAL

Traditional Chinese herbal drug

Drug: herbal drug

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

herbal drug DRUG

herbal drug

placebo DRUG

Placebo

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• h of onset did not receive cranial aneurysm embolization or craniotomy for aneurysm surgery were;

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Science and Technology Agency

Guangzhou, Guangdong, 510033, China

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: April 26, 2013
• Study Start: July 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

CN (1)