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

NCT03851809 | Completed Phase 2 DMC

• 1 other identifier: REC103-26
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Brain Injury

Keywords

traditional chinese medicine combination treatment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Glasgow coma scale

  6 month

• modified Rankin scale

  6 month

• Disability rating scale

  6 month

• Barthel index

  6 months

Study Arms (1)

neurologic intensive care in acute brain injury

EXPERIMENTAL

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

Interventions

Wendan decoction combination in acute brain injury DRUG

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.

neurologic intensive care in acute brain injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Tzu Chi Hospital: lead

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: no masking design
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurosurgery department

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 22, 2019
• Study Start: June 1, 2014
• Primary Completion: July 31, 2015
• Study Completion: January 31, 2016
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share