ITMCTR2100004343招募中1 期
Multicenter Clinical study on Fuyuan Tongluo granule in the treatment of Kidney deficiency and Blood stasis Syndrome in recovery stage of paralysis after Cerebral Infarction
The Affiliated Hospital of Hunan Academy of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 30 至 75（—）
- 性别
- All
入选标准
- •1. It conforms to the diagnostic standard of western medicine for cerebral infarction.
- •2. In line with the diagnostic criteria of apoplexy syndrome of kidney deficiency and blood stasis, the diagnostic criteria of middle meridian disease and the convalescence stage criteria.
- •3. The first onset, and head CT or MRI indicated a single lesion in the blood supply area of unilateral and middle cerebral artery.
- •4. with varying degrees of limb movement dysfunction, simplified fugl-meyer score < 96, modified Rankin scale score > 2, BI score < 60.
- •5. After voluntary enrollment, the Chinese and western drugs and non-drug treatments for cerebral infarction other than those specified in this protocol shall be discontinued.
- •6. Age is between 30 and 75 years old.
- •7. Patients or their family members voluntarily participate in and sign the informed consent.
排除标准
- •1. Cerebral hemorrhage confirmed by CT or MRI.
- •2. Patients with previous history of stroke.
- •3. Cerebral infarction in acute phase or sequela period.
- •4. For patients with mild cerebral infarction, simplified Fugl-Meyer score >= 96, modified Rankin scale score <= 2, BI score >= 60, and non-disabling or rapidly improving stroke patients, including transient ischemic attack, etc.
- •5. Patients with severe cerebral infarction accompanied by consciousness disorder, CT or MRI showed large cerebral infarction (involving more than 1 lobe area or more than 1/3 of the middle cerebral artery supply area), obvious brain mass effect, with CT or MRI signs of midline structure shift.
- •6. All landowners physical activities of cerebral infarction caused by disorders such as Parkinson's disease, rheumatoid arthritis, gouty arthritis, claudication, etc., as well as combination of cerebral infarction complications, such as depression, anxiety, dementia, epilepsy after cerebral infarction, shoulder joint subluxation, shoulder hand syndrome and lower extremity deep venous thrombosis, gastrointestinal bleeding, pulmonary infection, urinary tract infections, etc., and concurrent cerebral hemorrhage after cerebral infarction, cerebral hemorrhage after infarction, the validity of this study hard to make sure the evaluators.
- •7. Today with heart, liver, lung, kidney, hematopoietic system and other serious primary diseases, ALT, AST > upper limit of the normal value of 1.5 times, Cr > upper limit of the normal value, and has clinical significance.
- •8. Pet-type patients with other intracranial lesions, such as arteriovenous malformations, aneurysms, neurotumors, brain trauma, multiple sclerosis, intracerebral parasites, epilepsy, hysteria paralysis, encephalitis, meningitis, hydrocephalus, cerebral amyloidosis and other patients.
- •9. Legally prescribed patients with disabilities, such as blindness, deafness, deafness, mental disorders and mental disorders, affect the evaluation of neurological function and cooperate with the examiner.
- •10. Doubt or have alcohol and drug abuse history, or according to the researcher's judgement, can reduce the possibility, follow-up difficult set of other conditions, such as working environment change often, living environment is not stable, etc.
- •11. Allergic constitution or studying drug ingredients known allergies.
- •12. Participated in other clinical subjects at the same time or within three months.
- •13. Have MRI contraindications.
- •14. Pregnancy or breastfeeding women.
- •15. Both Yang hyperactivity or fire.
研究者
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