The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules
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ClinicalTrials.gov Identifier: NCT04950933 |
Recruitment Status :
Recruiting
First Posted : July 6, 2021
Last Update Posted : July 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Drug: Huolingshengji Granules Drug: Riluzole tablet | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | June 1, 2020 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
---|---|
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; |
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. |
- ALSFRS-R scores [ Time Frame: 48 weeks ]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.
- FVC% [ Time Frame: 48 weeks ]Change in FVC% from baseline after 48 weeks of treatment

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Ages Eligible for Study: | 45 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950933
Contact: Dongsheng Fan | +86 13701023871 | dsfan@sina.com |
China | |
Peking University Third Hospital | Recruiting |
Beijin, China | |
Contact: Dongsheng Fan 13701023871 dsfan@sina.com |
Principal Investigator: | Dongsheng Fan | Peking University Third Hospital |
Responsible Party: | Peking University Third Hospital |
ClinicalTrials.gov Identifier: | NCT04950933 |
Other Study ID Numbers: |
D2020076 |
First Posted: | July 6, 2021 Key Record Dates |
Last Update Posted: | July 8, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies |
Metabolic Diseases Riluzole Anticonvulsants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neuroprotective Agents Protective Agents |