A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS).

Peking University Third Hospital0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

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•1. Patients diagnosed as ALS (clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS).
•2. Each term of the ALSFRS-R must be more than 2 points (dyspnea, orthopnea, and respiratory insufficiency must be 4 points).
•3. FCV% >= 70%.
•4. Course of disease must be 3 years or less,counting from the first onset of any symptoms of ALS.
•5. TCM syndrome differentiation is spleen qi deficiency and kidney yang deficiency.
•6. Patients aged 40 years to 78 years old (including), male or female.
•7. Patients who voluntary participate in the clinical trial, and signed informed consent.

•1. Patients diagnosed as familial ALS.
•2. Patients who underwent gastrostomy.
•3. Patients with other neurological diseases which have similar symptoms to ALS, or affecting the evaluation of efficacy, such as cervical spondylotic myelopathy, lumbar spondylosis, dementia, etc.
•4. Patients with motor nerve block, sensory nerve conduction abnormalities detected by electromyography, and those with parenchymal lesions that could explain the clinical findings detected by imaging (CT or MRI).
•5. Patients who had used riluzole or edaravone within 3 months before enrollment.
•6. Patients who underwent spinal surgery after ALS onset.
•7. AST or ALT > 1.5 x UNL SCr > UNL.
•8. Patients with other severe neurological, cardiac, pulmonary, haematopoietic or endocrine primary disorders and psychiatric disorders.
•9. Patients with alcohol or drug abuse.
•10. Pregnant or lactating female, patients of reproductive age (including male patients with heterosexual sex and their female partners of childbearing potential) from initiation of screening to within 3 months of discontinuation who have a pregnancy plan or are unwilling to use effective contraception.
•11. Allergy to test drugs or the excipients.
•12. Patients who participated in another clinical study within 3 months.
•13. Patients with other conditions that the investigators consider those unsuitable to participate in this clinical trial.

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