China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT04885374
• Lead Sponsor: Dongzhimen Hospital, Beijing

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 Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-08
• Study First Submitted QC: 2021-05-08
• Last Update Submitted: 2021-05-08
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13
• Primary Completion: 2027-05-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effective Survival	Through study completion, an average of 3 months	The time from disease onset to death, tracheostomy, or permanent assisted ventilation

Secondary Outcome Measures

Name	Time	Method
Rate of Disease Progression	Through study completion, an average of 3 months	(48-total ALSFRS-R)/symptom duration (months)
Rate of Forced Vital Capacity (FVC) Decline	through study completion, an average of 3 months	The slope of decline of forced vital capacity (FVC) to assess the respiratory function.
Overall Survival	Through study completion, an average of 3 months	Death owing to any causes
Rate of Body Mass Index (BMI) Decline	Through study completion, an average of 3 months	The slope of decline of body mass index (BMI) to assess the disease progression.

Trial Locations

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China