China Amyotrophic Lateral Sclerosis Registry of Patients... | NCT04885374

Studies
China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

NCT04885374

Sponsor

Dongzhimen Hospital, Beijing

Status

Recruiting

Last Update Posted

May 13, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

May 1, 2027Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

May 8, 2021

First Submission Date that Met QC Criteria

May 8, 2021

First Posted Date

May 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2021

Last Update Posted Date

May 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amyotrophic lateral sclerosis patients		Amyotrophic lateral sclerosis patients with traditional Chinese medicine

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Death owing to any causes	Through study completion, an average of 3 months
Rate of Disease Progression	(48-total ALSFRS-R)/symptom duration (months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Gao, MD, PhD	Contact	+86-10-84013209		gaoying973@126.com

Overall Officials

Name	Affiliation	Role
Ying Gao, MD, PhD	Dongzhimen Hospital, Beijing	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongzhimen Hospital, Beijing University of Chinese Medicine	Recruiting	Beijing		100700	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38867220	Derived	Jia Q, Song Y, Zhang C, Li M, Feng L, Sugimoto K, Zhang X, Liu J, Gao Y. Reasons and experience for patients with amyotrophic lateral sclerosis using traditional Chinese medicine: a CARE-TCM based mixed method study. BMC Complement Med Ther. 2024 Jun 12;24(1):231. doi: 10.1186/s12906-024-04513-2.
34699945	Derived

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease