Back to resultsSafety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
Primary Purpose
Acute Brain Injury
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Wendan decoction combination in acute brain injury
Sponsored by
About this trial
This is an interventional treatment trial for Acute Brain Injury focused on measuring traditional chinese medicine combination treatment
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neurologic intensive care in acute brain injury
Arm Description
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.
Outcomes
Primary Outcome Measures
Ventilator use
how many days of ventilator use
ICU stay
how many days of ICU stay
Glasgow coma scale
from 3 to 15 , higher value indicate better outcome
Disability rating scale
from 0 to 29 , higher value mean worse outcome
modified Rankin scale
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
mortality
between 1 month mortality
Secondary Outcome Measures
Glasgow coma scale
from 3 to 15 , higher value indicate better outcome
modified Rankin scale
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
Disability rating scale
from 0 to 29 , higher value mean worse outcome
Barthel index
from 0 to 100 , higher value mean independency daily life care and better outcome
Full Information
NCT ID
NCT03851809
First Posted
February 13, 2019
Last Updated
February 21, 2019
Sponsor
Taichung Tzu Chi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03851809
Brief Title
Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
Official Title
A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
January 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Tzu Chi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Brain Injury
Keywords
traditional chinese medicine combination treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
randomized clinical trial
Masking
None (Open Label)
Masking Description
no masking design
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neurologic intensive care in acute brain injury
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Wendan decoction combination in acute brain injury
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator use
Description
how many days of ventilator use
Time Frame
1 month
Title
ICU stay
Description
how many days of ICU stay
Time Frame
1 month
Title
Glasgow coma scale
Description
from 3 to 15 , higher value indicate better outcome
Time Frame
1 month
Title
Disability rating scale
Description
from 0 to 29 , higher value mean worse outcome
Time Frame
1 month
Title
modified Rankin scale
Description
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
Time Frame
1 month
Title
mortality
Description
between 1 month mortality
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Glasgow coma scale
Description
from 3 to 15 , higher value indicate better outcome
Time Frame
6 month
Title
modified Rankin scale
Description
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
Time Frame
6 month
Title
Disability rating scale
Description
from 0 to 29 , higher value mean worse outcome
Time Frame
6 month
Title
Barthel index
Description
from 0 to 100 , higher value mean independency daily life care and better outcome
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
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