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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Brain Injury
• Intervention / Treatment: Drug: Wendan decoction combination in acute brain injury

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taichung Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): July 31, 2015
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: traditional chinese medicine combination treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: REC103-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No