The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules

NCT04950933 | Unknown Phase 2 DMC

• 1 other identifier: D2020076
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• FVC%

  48 weeks

Study Arms (2)

Test group

EXPERIMENTAL

Drug: Huolingshengji Granules

Control group

PLACEBO COMPARATOR

Drug: Riluzole tablet

Interventions

Huolingshengji Granules DRUG

1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally;

Test group

Riluzole tablet DRUG

Huolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally.

Control group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• The Second Hospital of Hebei Medical University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijin, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dongsheng Fan

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan

CONTACT

+86 13701023871; dsfan@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: June 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)