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

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ClinicalTrials.gov Identifier: NCT03851809
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Borren Huang, 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.

Condition or disease Intervention/treatment Phase
Acute Brain Injury Drug: Wendan decoction combination in acute brain injury Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: randomized clinical trial
Masking: None (Open Label)
Masking Description: no masking design
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : July 31, 2015
Actual Study Completion Date : January 31, 2016

Arm Intervention/treatment
Experimental: neurologic intensive care 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.
Drug: Wendan decoction combination in acute brain injury
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 Measures :
  1. Ventilator use [ Time Frame: 1 month ]
    how many days of ventilator use

  2. ICU stay [ Time Frame: 1 month ]
    how many days of ICU stay

  3. Glasgow coma scale [ Time Frame: 1 month ]
    from 3 to 15 , higher value indicate better outcome

  4. Disability rating scale [ Time Frame: 1 month ]
    from 0 to 29 , higher value mean worse outcome

  5. modified Rankin scale [ Time Frame: 1 month ]
    from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome

  6. mortality [ Time Frame: 1 month ]
    between 1 month mortality


Secondary Outcome Measures :
  1. Glasgow coma scale [ Time Frame: 6 month ]
    from 3 to 15 , higher value indicate better outcome

  2. modified Rankin scale [ Time Frame: 6 month ]
    from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome

  3. Disability rating scale [ Time Frame: 6 month ]
    from 0 to 29 , higher value mean worse outcome

  4. Barthel index [ Time Frame: 6 months ]
    from 0 to 100 , higher value mean independency daily life care and better outcome



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Borren Huang, Director of Neurosurgery department, Taichung Tzu Chi Hospital
ClinicalTrials.gov Identifier: NCT03851809     History of Changes
Other Study ID Numbers: REC103-26
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Borren Huang, Taichung Tzu Chi Hospital:
traditional chinese medicine combination treatment
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System