The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    144
  • sponsor
    Peking University Third Hospital
Updated on 18 July 2021
deficit
primary lateral sclerosis
riluzole

Summary

This study intends to evaluate the efficacy and safety of Dong Lingsheng Ji Granule in the treatment of amyotrophic lateral sclerosis (spleen deficiency, kidney-yang deficiency syndrome) in comparison with riluzole, so as to provide data support for marketing application or subsequent clinical research design.

Description

This study proposed the multicenter, randomized, double-blind, double simulation, positive drug parallel contrast the bad effect of experimental design, into the treatment group 72 cases, control group of 72 cases with the azole comparison, evaluation Dong Ling raw grain treatment on muscle atrophy amyotrophic lateral sclerosis (lack of temper, kidney Yang deficiency syndrome) efficacy and safety, for applications or follow-up clinical study design to provide data support.

Details
Condition lou gehrig's disease, Spinal Cord Disorders, Myelopathy, Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis
Treatment Huolingshengji Granules, Riluzole tablet
Clinical Study IdentifierNCT04950933
SponsorPeking University Third Hospital
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Meet the Western diagnostic criteria for amyotrophic lateral sclerosis (ALS) (clinically confirmed ALS, clinically likely ALS or clinically likely ALS- laboratory support)
The score of the modified amyotrophic lateral sclerosis function scale (ALSFRS-R) was 2 points for each item (among which dyspnea, sitting breathing and respiratory insufficiency were all 4 points)
The percentage of forced vital capacity in the predicted value (FVC%) 70%
the duration of the disease is 3 years or less (from the first onset of any symptoms of ALS)
TCM syndrome differentiation for deficiency of temper, kidney Yang deficiency syndrome
Age 45-70 (including 45 and 70), gender unlimited
Voluntarily participate in the clinical trial, give informed consent and sign informed consent

Exclusion Criteria

(1) Patients diagnosed with familial ALS; (2) Those who
have undergone gastrostomy; (3) patients with other neurological diseases
similar to ALS, such as cervical spondylotic myelopathy, lumbar spondylopathy
dementia, etc., which may affect the evaluation of drug effectiveness; (4)
electromyogram detection found motor nerve conduction block, sensory nerve
conduction abnormality, imaging examination (CT or MRI) found that can explain
the clinical manifestations of substantial lesions; (5) Patients who had been
treated with riluzole or edaravone within 3 months before enrollment; (6)
patients with a history of spinal surgery after the onset of ALS; (7)
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5
times the upper limit of the normal reference value, or blood muscle (SCR) >
Upper limit of normal reference value; (8) Patients with other serious primary
diseases of the nervous system, heart, lung, hematopoietic system or endocrine
system and psychosis; (9) Suspected or have a history of alcohol and drug
abuse; (10) Pregnant women or lactating women, subjects of reproductive age
(including male subjects with heterosexual behavior and their female partners
with fertility potential) have pregnancy plans or are unwilling to take
effective contraceptive measures within 3 months from the beginning of
screening to the end of drug withdrawal; (11) People who are known or
suspected to have a history of allergy to the test drug and its excipients
(12) Screening participants who had participated in other clinical trials
within the previous 3 months; (13) Those considered by the researcher to be
unsuitable to participate in this clinical trial
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