China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine (CARE-TCM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04885374|
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
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|Condition or disease|
|Amyotrophic Lateral Sclerosis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|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|
Amyotrophic lateral sclerosis patients
Amyotrophic lateral sclerosis patients with traditional Chinese medicine
- Effective Survival [ Time Frame: Through study completion, an average of 3 months ]The time from disease onset to death, tracheostomy, or permanent assisted ventilation
- Overall Survival [ Time Frame: Through study completion, an average of 3 months ]Death owing to any causes
- Rate of Disease Progression [ Time Frame: Through study completion, an average of 3 months ](48-total ALSFRS-R)/symptom duration (months)
- 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.
- 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|
- 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.
- Patients who refuse informed consent.
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
|Contact: Ying Gao, MD, PhDemail@example.com|
|Dongzhimen Hospital, Beijing University of Chinese Medicine||Recruiting|
|Beijing, China, 100700|
|Contact: Ying Gao, MD, PhD +86-10-84013209 firstname.lastname@example.org|
|Principal Investigator:||Ying Gao, MD, PhD||Dongzhimen Hospital, Beijing University of Chinese Medicine|
|Responsible Party:||Ying Gao, MD, PhD, Professor, Dongzhimen Hospital, Beijing|
|Other Study ID Numbers:||
|First Posted:||May 13, 2021 Key Record Dates|
|Last Update Posted:||May 13, 2021|
|Last Verified:||May 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases