Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma: a a Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Rate of operation
研究概览
简要总结
A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.
详细描述
The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of the Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH in an effort to prevent surgery. The investigators hypothesize that, compared with placebo, the Chinese herbal formula HXLS reduce incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and the placebo group at a 1:1 ratio.
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)
盲法说明
The investigators in charge of the recruitment and follow-up evaluation and participants will be blinded, along with the outcome assessors and data analysts.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years and either gender will be included.
- •Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).
- •Primary hematoma or residual hematoma after burr-hole drainage.
- •Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤
- •No risk of brain herniation or recent immediate need for surgery will be evaluated by 2 attending neurosurgeons.
- •Written informed consent will be obtained from patients or their next of kins according to their cognitive status.
排除标准
- •Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.
- •Progressive or apparent neurological deficit with a GCS score < 14 or mRS score >
- •Midline shift > 10 mm on the radiological image.
- •Previous medication treatment for CSDH.
- •Previous intracranial surgery for any other neurological disorder.
- •Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma.
- •Known hypersensitivity or allergy to HXLS or to any of the ingredients.
- •Malignant tumors.
- •Life expectancy of < 1 year.
- •Abnormal liver function or liver diseases, including uncontrolled hepatitis (alanine transaminase > 120 U/L).
- •Severe renal impairment (estimated glomerular filtration rate < 30 ml/min or serum creatinine > 150 μmol/L).
- •Moderate or severe anemia (hemoglobin ≤ 90 g/L).
- •Severe coagulopathy or a high risk of life-threatening bleeding.
- •Poor medication conditions or the presence of severe comorbidities such that treatment cannot be tolerated or follow-up cannot be completed.
- •Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, angiotensin-converting enzyme inhibitors, or other traditional Chinese medicines before randomization or are expected to take such medications in the next 24 weeks.
- •Difficulty swallowing oral medication.
- •Pregnancy or lactation.
- •Participating in another study.
研究组 & 干预措施
HXLS group
The HXLS granules are produced from four Chinese herbal pieces: Yi Mu Cao (Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (Hirudo, 1.5g), Tao Ren (Semen persicae, 6.0g), and Hong Hua (Carthamus tinctorius L, 6.0g).
干预措施: Chinese Herbal formula HuoXue LiShui (Drug)
placebo group
The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. It included Hu Jing (28.0g)
干预措施: Chinese Herbal formula Placebo (Drug)
结局指标
主要结局
Rate of operation
时间窗: From baseline up to 24 weeks after the start of treatment with the study medication
Surgical rate of hematoma recurrence due to progression of primary hematoma or after burr hole drainage
次要结局
- Chronic subdural hematoma volume(At baseline, and at 4, 8 and 24 weeks)
- Number of falling incidents(At 24 weeks)
- Change of Modified Rankin Scale (MRS) between group(At baseline, and at 4, 8, and 24 weeks)
- Change of performance in activities of daily living(At baseline, and at 4, 8, and 24 weeks)
- Rate of complications and adverse events between groups(Within 24 weeks)
- Change of Markwalder Grading Scale (MGS) between groups(At baseline, and at 4, 8, and 24 weeks)
- Change of Quality of life(At baseline, and at 4, 8, and 24 weeks)
- Change of cognitive functioning(At baseline, and at 4, 8, and 24 weeks)
- Mortality(At 24 weeks)
研究者
Weiming Liu
Professor
Beijing Tiantan Hospital