Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Guangzhou University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01840761
First received: December 12, 2011
Last updated: April 25, 2013
Last verified: April 2013

December 12, 2011
April 25, 2013
July 2010
December 2015   (final data collection date for primary outcome measure)
The incidence of DCVS after aneurysmal postoperative [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine
Same as current
Complete list of historical versions of study NCT01840761 on ClinicalTrials.gov Archive Site
1 month, 3 month mortality [ Time Frame: 14days,1 month,3 month ] [ Designated as safety issue: Yes ]
after 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine
Same as current
Not Provided
Not Provided
 
Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine
Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Aneurysm
  • Drug: herbal drug
  • Drug: placebo
  • Experimental: herbal drug
    Traditional Chinese herbal drug
    Intervention: Drug: herbal drug
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
December 2015   (final data collection date for primary outcome measure)

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;
Both
14 Years to 80 Years
Yes
China
 
NCT01840761
2010B030700029, 2010B030700029
Yes
Guangzhou University of Traditional Chinese Medicine
Guangzhou University of Traditional Chinese Medicine
Not Provided
Not Provided
Guangzhou University of Traditional Chinese Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP