China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04885374

Acronym

CARE-TCM

Enrollment

2000

Registered

2021-05-13

Start date

2021-03-01

Completion date

2028-03-01

Last updated

2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall Survival	Through study completion, an average of 3 months	Death owing to any causes
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.
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.

Countries

China

Contacts

Primary ContactYing Gao, MD, PhD

gaoying973@126.com+86-10-84013209

Outcome results