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

• Status: Completed
• Trial end date: 2016-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taichung Tzu Chi Hospital

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.