Status:
COMPLETED
Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
Lead Sponsor:
Taichung Tzu Chi Hospital
Conditions:
Acute Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 r...
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03851809
Start Date
June 1 2014
End Date
January 31 2016
Last Update
February 22 2019
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