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

Taichung Tzu Chi Hospital60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Brain Injury

Interventions

Wendan decoction combination in acute brain injuryDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Ventilator use

how many days of ventilator use

Time frame: 1 month

ICU stay

how many days of ICU stay

Time frame: 1 month

Glasgow coma scale

from 3 to 15 , higher value indicate better outcome

Time frame: 1 month

Disability rating scale

from 0 to 29 , higher value mean worse outcome

Time frame: 1 month

modified Rankin scale

from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome

Time frame: 1 month

mortality

between 1 month mortality

Time frame: 1 month

Secondary Outcomes

Glasgow coma scale

from 3 to 15 , higher value indicate better outcome

Time frame: 6 month

modified Rankin scale

from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome

Time frame: 6 month

Disability rating scale

from 0 to 29 , higher value mean worse outcome

Time frame: 6 month

Data from ClinicalTrials.gov

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