NCT03851809

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Taichung Tzu Chi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-07-31
• Completion: 2016-01-31
• First posted: 2019-02-22
• Last updated: 2019-02-22