China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Effective Survival [Time frame: Through study completion, an average of 3 months]
Secondary outcome measures (4)
- Overall Survival [Time frame: Through study completion, an average of 3 months]
- Rate of Disease Progression [Time frame: Through study completion, an average of 3 months]
- Rate of Forced Vital Capacity (FVC) Decline [Time frame: through study completion, an average of 3 months]
- Rate of Body Mass Index (BMI) Decline [Time frame: Through study completion, an average of 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Dongzhimen Hospital, Beijing University of Chinese Medicine — Beijing
Publications
- 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 38867220
- 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. PMID 34699945
Identifiers
NCT: NCT04885374 · ALS-2021-CARE-TCM