China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine (CARE-TCM)

May 8, 2021 updated by: Ying Gao, Dongzhimen Hospital, Beijing
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100700
        • Recruiting
        • Dongzhimen Hospital, Beijing University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the criteria will be enrolled from multi-centers in China.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Amyotrophic lateral sclerosis patients
Amyotrophic lateral sclerosis patients with traditional Chinese medicine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Through study completion, an average of 3 months
Death owing to any causes
Through study completion, an average of 3 months
Rate of Disease Progression
Time Frame: Through study completion, an average of 3 months
(48-total ALSFRS-R)/symptom duration (months)
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
The slope of decline of forced vital capacity (FVC) to assess the respiratory function.
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
The slope of decline of body mass index (BMI) to assess the disease progression.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongzhimen Hospital, Beijing

Investigators

  • Principal Investigator: Ying Gao, MD, PhD, Dongzhimen Hospital, Beijing University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

May 1, 2027

Study Completion (Anticipated)

March 1, 2028

Study Registration Dates

First Submitted

May 8, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 8, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS-2021-CARE-TCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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