China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Amyotrophic Lateral Sclerosis Clinical Trial

— CARE-TCM  

Official title:

China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885374
• Other study ID #: ALS-2021-CARE-TCM
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 1, 2028

Study information

• Verified date: May 2021
• Source: Dongzhimen Hospital, Beijing
• Contact: Ying Gao, MD, PhD
• Phone: +86-10-84013209
• Email: gaoying973[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
China	Dongzhimen Hospital, Beijing University of Chinese Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Survival	The time from disease onset to death, tracheostomy, or permanent assisted ventilation	Through study completion, an average of 3 months
Secondary	Overall Survival	Death owing to any causes	Through study completion, an average of 3 months
Secondary	Rate of Disease Progression	(48-total ALSFRS-R)/symptom duration (months)	Through study completion, an average of 3 months
Secondary	Rate of Forced Vital Capacity (FVC) Decline	The slope of decline of forced vital capacity (FVC) to assess the respiratory function.	through study completion, an average of 3 months
Secondary	Rate of Body Mass Index (BMI) Decline	The slope of decline of body mass index (BMI) to assess the disease progression.	Through study completion, an average of 3 months