Safety and Efficacy of MLC901 (NeuroAiD Ii) in Patients With Moderate TBI: A Randomized Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- GOS-E at 6 months
研究概览
简要总结
This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.
详细描述
This is a double blind placebo controlled randomized trial to determine whether giving MLC901 for 6 months will improve the outcomes in a adult patients with moderate traumatic brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Moderate TBI
- •Presenting at the study site within 7 days of injury
- •Participant or his/her legal representative able to comply with the study protocol and willing to provide written informed consent
排除标准
- •Penetrating HI
- •Co-existing severe or unstable injury
- •Physician's medical judgment that surgical intervention is likely within the next 48 hours
- •Physician's medical judgment that participation is not in the participant's best interest
- •Pre-injury mRS>2
- •Pregnancy
- •Inability to take study drug orally or via NGT
- •Participation in another investigational drug study
- •Intake of nootropic drugs which are not standard TBI medications
研究组 & 干预措施
Placebo
This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
干预措施: Placebo (Genetic)
MLC901 (NeuroAiD II)
This consists of extracts from 9 herbal components in a dark blue/light blue capsule
干预措施: MLC901 (Dietary Supplement)
结局指标
主要结局
GOS-E at 6 months
时间窗: 18 months
This is the most widely used TBI outcome measure with the extended version ranging from 0 (dead) to 8 (full recovery)
次要结局
- Safety until 9 months: adverse events(18 months)
- Glasgow Coma Scale (GCS) at baseline, 1, 3, 6 & 9 months(18 months)
- Frontal Assessment Battery at 1,3,6 & 9 monts(18 months)
- EQ-5D at 1,3,6 & 9 months (EuroQol Group)(18 months)
- Mortality at 6 months(18 months)
- Glasgow Outcome Scale Extended (GOS-E) at baseline, 1,3 & 9 months(18 months)
- Montreal Cognitive Assessment Filipino Version (MoCA-P) at 1,3,6 & 9 months(18 months)
- RiverMead Postconcussion Symptome Questionnaire Score at 1,3,6 & 9 months(18 months)
- Compliance until 6 months(18 months)
- Cerebral swelling at baseline, 1 & 2 weeks(18 months)
- Barthel Index (BI) at 1,3,6 & 9 months(18 months)
- Hospital Anxiety and Depression Scale at 1,3,6 & 9 months(18 months)
研究者
Annabell Chua
Principal Investigator
University of the Philippines