China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
CARE-TCM
1 other identifier
observational
2,000
1 country
1
Brief Summary
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 8, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 13, 2021
May 1, 2021
6.2 years
May 8, 2021
May 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Effective Survival
The time from disease onset to death, tracheostomy, or permanent assisted ventilation
Through study completion, an average of 3 months
Secondary Outcomes (4)
Overall Survival
Through study completion, an average of 3 months
Rate of Disease Progression
Through study completion, an average of 3 months
Rate of Forced Vital Capacity (FVC) Decline
through study completion, an average of 3 months
Rate of Body Mass Index (BMI) Decline
Through study completion, an average of 3 months
Study Arms (1)
Amyotrophic lateral sclerosis patients
Amyotrophic lateral sclerosis patients with traditional Chinese medicine
Eligibility Criteria
Patients who meet the criteria will be enrolled from multi-centers in China.
You may qualify if:
- 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.
You may not qualify if:
- Patients who refuse informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, 100700, China
Related Publications (2)
Jia Q, Song Y, Zhang C, Li M, Feng L, Sugimoto K, Zhang X, Liu J, Gao Y. Reasons and experience for patients with amyotrophic lateral sclerosis using traditional Chinese medicine: a CARE-TCM based mixed method study. BMC Complement Med Ther. 2024 Jun 12;24(1):231. doi: 10.1186/s12906-024-04513-2.
PMID: 38867220DERIVEDSong 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.
PMID: 34699945DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Gao, MD, PhD
Dongzhimen Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Professor
Study Record Dates
First Submitted
May 8, 2021
First Posted
May 13, 2021
Study Start
March 1, 2021
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
May 13, 2021
Record last verified: 2021-05