The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules

A Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome)

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Drug: Huolingshengji Granules; Drug: Riluzole tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijin, China
    • Recruiting
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet the Western diagnostic criteria for amyotrophic lateral sclerosis (ALS) (clinically confirmed ALS, clinically likely ALS or clinically likely ALS- laboratory support);
2. 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);
3. The percentage of forced vital capacity in the predicted value (FVC%) ≥70%;
4. the duration of the disease is 3 years or less (from the first onset of any symptoms of ALS);
5. TCM syndrome differentiation for deficiency of temper, kidney Yang deficiency syndrome;
6. Age 45-70 (including 45 and 70), gender unlimited;
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control group	Drug: Riluzole tablet; Huolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally.
EXPERIMENTAL: Test group	Drug: Huolingshengji Granules; 1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALSFRS-R scores	Changes in ALSFRS-R scores from baseline after 48 weeks of treatment, The ALSFRS-R scale (ALS Functional Rating Scale) includes 12 items including medulla oblongata function, limb function and respiratory function, with a total score of 48. The lower the score, the more serious the neurological function damage.	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FVC%	Change in FVC% from baseline after 48 weeks of treatment	48 weeks

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (ACTUAL): July 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neuroprotective Agents; Protective Agents; Anticonvulsants; Riluzole
• Other Study ID Numbers: D2020076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No