Acute Brain InjuryPhase 2/3NCT03851809
Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury
A Phase 2/3 study testing Wendan decoction combination in acute brain injury in people with Acute Brain Injury, run by Taichung Tzu Chi Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Brain Injury
- What is being tested?
- Wendan decoction combination in acute brain injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Jan 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Wendan decoction combination in acute brain injury
- Keywords
- traditional chinese medicine combination treatment
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wendan decoction combination in acute brain injuryDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Wendan decoction combination in acute brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator use
how many days of ventilator use
Measured: 1 month
ICU stay
how many days of ICU stay
Measured: 1 month
Glasgow coma scale
from 3 to 15 , higher value indicate better outcome
Measured: 1 month
Disability rating scale
from 0 to 29 , higher value mean worse outcome
Measured: 1 month
modified Rankin scale
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
Measured: 1 month
mortality
between 1 month mortality
Measured: 1 month
Secondary outcomes (4)
Glasgow coma scale
from 3 to 15 , higher value indicate better outcome
Measured: 6 month
modified Rankin scale
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
Measured: 6 month
Disability rating scale
from 0 to 29 , higher value mean worse outcome
Measured: 6 month
Barthel index
from 0 to 100 , higher value mean independency daily life care and better outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Jun 2014
- Primary completion31 Jul 2015
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borren Huang, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851809
- Sponsor's protocol ID
- REC103-26
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury
- ClinicalTrials.gov ID
- NCT03851809
- Acronym / sponsor ID
- REC103-26
- Conditions
- Acute Brain Injury
- Keywords
- traditional chinese medicine combination treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| neurologic intensive care in acute brain injury | Experimental | Drug: Wendan decoction combination in acute brain injuryWith 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wendan decoction combination in acute brain injuryIn the intervention group, traditional Chinese medicine was given between 14 days of onset and TCM was used 1 month at least in intervention group. | Drug | neurologic intensive care in acute brain injury |
Primary outcome
Ventilator use
Time frame: 1 month
how many days of ventilator use
ICU stay
Time frame: 1 month
how many days of ICU stay
Glasgow coma scale
Time frame: 1 month
from 3 to 15 , higher value indicate better outcome
Disability rating scale
Time frame: 1 month
from 0 to 29 , higher value mean worse outcome
modified Rankin scale
Time frame: 1 month
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
mortality
Time frame: 1 month
between 1 month mortality
4 secondary outcomes
Glasgow coma scale
Time frame: 6 month
modified Rankin scale
Time frame: 6 month
Disability rating scale
Time frame: 6 month
Barthel index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
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Caregiver Distress, Emotional Distress
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Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
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Fareon Open Label Device Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Wendan decoction combination in acute brain injury in people with Acute Brain Injury, run by Taichung Tzu Chi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator use (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.