Study Purpose:
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational [Patient Registry]
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Ying Gao, MD, PhD, Dongzhimen Hospital, Beijing University of Chinese Medicine
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Ying Gao, MD, PhD / email hidden; JavaScript is required / +86-10-84013209
Full Study Summary:
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 Sponsor:
Dongzhimen Hospital, Beijing
Estimated Enrollment:
2000
Estimated Study Start Date:
03 / 01 / 2021
Estimated Study Completion Date:
03 / 01 / 2028
Posting Last Modified Date:
05 / 13 / 2021
Date Study Added to neals.org:
05 / 13 / 2021
Minimum Age:
18 Years
Maximum Age:
N/A
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.
Dongzhimen Hospital, Beijing University of Chinese Medicine | Recruiting
Ying Gao, MD, PhD / +86-10-84013209 / email hidden; JavaScript is required
Beijing 100700
China