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China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine (CARE-TCM)

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ClinicalTrials.gov Identifier: NCT04885374
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Ying Gao, Dongzhimen Hospital, Beijing

Brief Summary:
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
The CARE-TCM is a prospective, multi-center, patient registry study. Eligible ALS patients with TCM treatments will be enrolled in the registry. After enrollment, this research collects the individual characteristics of patients' status. Longitudinal follow-up data are collected from both patients (primary caregivers) and their treating neurologists every 3 months for 5 years. The aims of the CARE-TCM are to: 1) explore the general characteristics of ALS patients with TCM and; 2) assess the effectiveness and safety of various TCMs on ALS based on nationwide registry outcome collecting process.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 1, 2027
Estimated Study Completion Date : March 1, 2028


Group/Cohort
Amyotrophic lateral sclerosis patients
Amyotrophic lateral sclerosis patients with traditional Chinese medicine



Primary Outcome Measures :
  1. Effective Survival [ Time Frame: Through study completion, an average of 3 months ]
    The time from disease onset to death, tracheostomy, or permanent assisted ventilation


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Through study completion, an average of 3 months ]
    Death owing to any causes

  2. Rate of Disease Progression [ Time Frame: Through study completion, an average of 3 months ]
    (48-total ALSFRS-R)/symptom duration (months)

  3. Rate of Forced Vital Capacity (FVC) Decline [ Time Frame: through study completion, an average of 3 months ]
    The slope of decline of forced vital capacity (FVC) to assess the respiratory function.

  4. Rate of Body Mass Index (BMI) Decline [ Time Frame: Through study completion, an average of 3 months ]
    The slope of decline of body mass index (BMI) to assess the disease progression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who meet the criteria will be enrolled from multi-centers in China.
Criteria

Inclusion Criteria:

  • Patients aged 18 years and older.
  • Patients with possible, laboratory supported probable, probable, or definite ALS according to the revised El Escorial criteria.
  • ALS patients treated with traditional Chinese medicine.

Exclusion Criteria:

  • Patients who refuse informed consent.

Information from the National Library of Medicine

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): NCT04885374


Contacts
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Contact: Ying Gao, MD, PhD +86-10-84013209 gaoying973@126.com

Locations
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China
Dongzhimen Hospital, Beijing University of Chinese Medicine Recruiting
Beijing, China, 100700
Contact: Ying Gao, MD, PhD    +86-10-84013209    gaoying973@126.com   
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Investigators
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Principal Investigator: Ying Gao, MD, PhD Dongzhimen Hospital, Beijing University of Chinese Medicine
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Responsible Party: Ying Gao, MD, PhD, Professor, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT04885374    
Other Study ID Numbers: ALS-2021-CARE-TCM
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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