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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
Sponsor:
Information provided by (Responsible Party):
Ying Gao, Dongzhimen Hospital, Beijing

Tracking Information
First Submitted Date May 8, 2021
First Posted Date May 13, 2021
Last Update Posted Date May 13, 2021
Actual Study Start Date March 1, 2021
Estimated Primary Completion Date May 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2021)		 Effective Survival [ Time Frame: Through study completion, an average of 3 months ]
The time from disease onset to death, tracheostomy, or permanent assisted ventilation
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 8, 2021)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
Official Title China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
Brief Summary A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who meet the criteria will be enrolled from multi-centers in China.
Condition Amyotrophic Lateral Sclerosis
Intervention Not Provided
Study Groups/Cohorts Amyotrophic lateral sclerosis patients
Amyotrophic lateral sclerosis patients with traditional Chinese medicine
Publications * Song Y, Li M, Sugimoto K, Han Y, Liu J, Ma B, Song H, Zhang C, Gao Y; CARE-TCM Group. China amyotrophic lateral sclerosis registry of patients with Traditional Chinese Medicine (CARE-TCM): Rationale and design. J Ethnopharmacol. 2022 Feb 10;284:114774. doi: 10.1016/j.jep.2021.114774. Epub 2021 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 8, 2021)		 2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2028
Estimated Primary Completion Date May 1, 2027   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ying Gao, MD, PhD +86-10-84013209 gaoying973@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04885374
Other Study ID Numbers ALS-2021-CARE-TCM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Ying Gao, Dongzhimen Hospital, Beijing
Original Responsible Party Same as current
Current Study Sponsor Dongzhimen Hospital, Beijing
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ying Gao, MD, PhD Dongzhimen Hospital, Beijing University of Chinese Medicine
PRS Account Dongzhimen Hospital, Beijing
Verification Date May 2021