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

Acute Brain Injury Clinical Trial

Official title:

A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851809
• Other study ID #: REC103-26
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1, 2014
• Est. completion date: January 31, 2016

Study information

• Verified date: February 2019
• Source: Taichung Tzu Chi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2016
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Tzu Chi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator use	how many days of ventilator use	1 month
Primary	ICU stay	how many days of ICU stay	1 month
Primary	Glasgow coma scale	from 3 to 15 , higher value indicate better outcome	1 month
Primary	Disability rating scale	from 0 to 29 , higher value mean worse outcome	1 month
Primary	modified Rankin scale	from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome	1 month
Primary	mortality	between 1 month mortality	1 month
Secondary	Glasgow coma scale	from 3 to 15 , higher value indicate better outcome	6 month
Secondary	modified Rankin scale	from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome	6 month
Secondary	Disability rating scale	from 0 to 29 , higher value mean worse outcome	6 month
Secondary	Barthel index	from 0 to 100 , higher value mean independency daily life care and better outcome	6 months