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

NCT ID: NCT03851809

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2016-01-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wendan decoction combination in acute brain injury

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Tzu Chi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Borren Huang

Director of Neurosurgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

REC103-26

Identifier Type: -

Identifier Source: org_study_id