Acute Brain Injury
Conditions
Keywords
traditional chinese medicine combination treatment
Brief summary
Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - A randomized controlled study.
Detailed description
This study adopted a prospective, randomized controlled design. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in this study and randomized into intervention group and control group. All patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. The intervention group mean regular neuro-intensive care combined TCM and the intervention group mean only neuro-intensive care. But there are 7 patients in intervention group and 12 patients in control group quit out this study
Interventions
DRUGWendan decoction combination in acute brain injury
In the intervention group, traditional Chinese medicine was given between 14 days of onset and TCM was used 1 month at least in intervention group.
Sponsors
Taichung Tzu Chi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking design
Intervention model description
randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset; * an initial score of 3-12 points of GCS score; * adults between 18 to 80 years old; * and signed informed consent form.
Exclusion criteria
* after 14 days of onset; * a history of previous TBI or stroke; * intracranial aneurysm or arteriovenous malformation ruptured; * combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels); * other severe disease such as heart or kidney failure; * previous diagnosed cancer; and pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 1 month | between 1 month mortality |
| ICU stay | 1 month | how many days of ICU stay |
| Glasgow coma scale | 1 month | from 3 to 15 , higher value indicate better outcome |
| Disability rating scale | 1 month | from 0 to 29 , higher value mean worse outcome |
| modified Rankin scale | 1 month | from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome |
| Ventilator use | 1 month | how many days of ventilator use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin scale | 6 month | from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome |
| Disability rating scale | 6 month | from 0 to 29 , higher value mean worse outcome |
| Barthel index | 6 months | from 0 to 100 , higher value mean independency daily life care and better outcome |
| Glasgow coma scale | 6 month | from 3 to 15 , higher value indicate better outcome |
Outcome results
None listed