China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

NCT ID: NCT04885374

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2028-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Amyotrophic lateral sclerosis patients

Amyotrophic lateral sclerosis patients with traditional Chinese medicine

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

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Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Gao, MD, PhD

Role: CONTACT

+86-10-84013209

Facility Contacts

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Ying Gao, MD, PhD

Role: primary

+86-10-84013209

References

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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.

Reference Type DERIVED
PMID: 38867220 (View on PubMed)

Song Y, Li M, Sugimoto K, Han Y, Liu J, Ma B, Song H, Zhang C, Gao Y; CARE-TCM Group. China amyotrophic lateral sclerosis registry of patients with Traditional Chinese Medicine (CARE-TCM): Rationale and design. J Ethnopharmacol. 2022 Feb 10;284:114774. doi: 10.1016/j.jep.2021.114774. Epub 2021 Oct 23.

Reference Type DERIVED
PMID: 34699945 (View on PubMed)

Other Identifiers

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ALS-2021-CARE-TCM

Identifier Type: -

Identifier Source: org_study_id

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