Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury

Study Overview
=================
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

Official Title
-----------------
A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury

Conditions
-----------------
Acute Brain Injury

Intervention / Treatment
-----------------
* Drug: Wendan decoction combination in acute brain injury


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neurologic intensive care in acute brain injury<br>With the guidance of Taiwan Neurosurgical Society and Taiwan Neurological Society, patients in the control group were given the consistent treatment. (http://www.neurosurgery.org.tw/nsr/tbi/main.htm and http://www.stroke.org.tw/guideline/guideline_1.asp). The intensive treatments were established according to the traumatic brain injury treatment guidelines and spontaneously intracerebral hemorrhage general treatment principles from these two society in Taiwan. | Drug: Wendan decoction combination in acute brain injury<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator use | how many days of ventilator use | 1 month | 
| ICU stay | how many days of ICU stay | 1 month | 
| Glasgow coma scale | from 3 to 15 , higher value indicate better outcome | 1 month | 
| Disability rating scale | from 0 to 29 , higher value mean worse outcome | 1 month | 
| modified Rankin scale | from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome | 1 month | 
| mortality | between 1 month mortality | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow coma scale | from 3 to 15 , higher value indicate better outcome | 6 month | 
| modified Rankin scale | from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome | 6 month | 
| Disability rating scale | from 0 to 29 , higher value mean worse outcome | 6 month | 
| Barthel index | from 0 to 100 , higher value mean independency daily life care and better outcome | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traditional chinese medicine combination treatment