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

Phase 2

Completed

• Conditions: Acute Brain Injury
• Interventions: Drug: Wendan decoction combination in acute brain injury

• Registration Number: NCT03851809
• Lead Sponsor: Taichung Tzu Chi Hospital

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

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2015-07-31
• Study Completion: 2016-01-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neurologic intensive care in acute brain injury	Wendan decoction combination in acute brain injury	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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