Dynamic Combination Therapy on Chinese Herbal Granules Based on Differentiation of Syndrome (Zhenghou)of Traditional Chinese Medicine to Improve the Symptoms in the Convalescent Phase of Ischemic Stroke: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28
研究概览
简要总结
To evaluate the effect of the dynamic combination therapy on Chinese herbal granule formula (Fangji) based on differentiation of syndromes ("Zhenghou") according to the theory of traditional Chinese medicine for improving the symptoms in the convalescent phase of ischemic stroke, and to establish the pharmacodynamic model of "Zhenghou" according to the results of this trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 75 years.
- •Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect, confirmed by CT or MRI scan.
- •Clinical diagnosis of "Qixu-Xueyu Zheng" (Qi deficiency and Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales in ischemic stroke on both "Qixue" and "Xueyu" ≥
- •15 days to 60 days after onset of symptoms.
- •Clinical diagnosis of cerebral anterior circulation obstruction.
- •4≤NIHSS<
- •Patient is willing to participate voluntarily and to sign a written patient informed consent.
排除标准
- •Transient ischemic attack
- •Evidence of intracranial hemorrhage (ICH) in 6 months
- •Evidence of other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT or MRI scan.
- •Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
- •Woman who is under menstrual period.
- •Known history of allergy or suspected allergic to these chinese herbs.
- •Complicated with atrial fibrillation.
- •Fasting blood glucose ≥8 mmol / l under the treatment of diabetes or complicated with severe cardio-cerebrovascular diseases (eg. hyperlipemia, coronary heart disease with angina attack ≥ 4 times a day).
- •Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
- •Renal dysfunction with the value of serum creatinine over normal value.
- •Prior disable patients or complicated with osteoarthropathy that influence the motor function of the limbs.
- •With mental disorder that can not cooperate with doctor
- •Suspected addicted into alcohol or drug abuse.
- •With severe complications that would make the condition more complicated assessed by the investigator.
- •Patient who is participating in other trials or has been participated in other trials in recent 3 months.
研究组 & 干预措施
Dynamic Chinese herbal granule formula
Based on standard medical care, after evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a combination therapy of a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules, including 3 gram of Huangqi(Astragalus root), 2 gram of Renshen(ginseng), 2.5 gram of Danggui(Angelica sinensis), 2 gram of Danshen(Salvia miltiorrhiza), 2 gram of Dilong(Geosaurus), 3 gram of Chishao(Radix Paeoniae Rubra), 2 gram of Honghua(Safflower), 2 gram of Chuanxiong(Rhizoma Chuanxiong), 2 gram of Sanqi(Radix Notoginseng), 3 gram of Shudihuang(Radix Rehmanniae Preparata). The Chinese herbal granule formula could be weekly changed according to differentiation of Zhenghou.
干预措施: Dynamic Chinese herbal granule formula (Drug)
Dynamic Chinese herbal granule formula
Based on standard medical care, after evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a combination therapy of a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules, including 3 gram of Huangqi(Astragalus root), 2 gram of Renshen(ginseng), 2.5 gram of Danggui(Angelica sinensis), 2 gram of Danshen(Salvia miltiorrhiza), 2 gram of Dilong(Geosaurus), 3 gram of Chishao(Radix Paeoniae Rubra), 2 gram of Honghua(Safflower), 2 gram of Chuanxiong(Rhizoma Chuanxiong), 2 gram of Sanqi(Radix Notoginseng), 3 gram of Shudihuang(Radix Rehmanniae Preparata). The Chinese herbal granule formula could be weekly changed according to differentiation of Zhenghou.
干预措施: Standard medical care (Procedure)
Placebo
The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
干预措施: Placebo (Drug)
Placebo
The process is the same as the experimental arm, except that the matched placebo granules should be in turn of Chinese herbal granules.
干预措施: Standard medical care (Procedure)
结局指标
主要结局
Symptom Scale of the "Qixu-Xueyu Zheng"(Qi Deficiency and Blood Stasis Syndrome) according to the theory of Traditional Chinese Medicine at Day 28
时间窗: Day 28
次要结局
- EQ-5D scale(Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset)
- Overall mortality at day 90(Day 90 after onset)
- Incidence of Recurrent Stroke(Day 90 after onset this time)
- Incidence of new-onset vascular events(Day 90 after onset this time)
- NIH stroke scale(NIHSS)(Day 0; Day7; Day 14; Day 21; Day 28; Day 90 after onset)
- Bathel Index(Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset)
- modified Rankin Scale(Day0; Day 7; Day 14; Day 21; Day 28; Day 90 after Onset)
- Incidence of adverse events (AEs) and serious AEs(From Day 0 to Day 90 after onset)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences