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NCT Number: NCT04885374

China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

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

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, 100700, China

Location status: Recruiting

Location contact

Ying Gao, MD, PhD

CONTACT

[email protected]

+86-10-84013209

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Effective Survival

    Time frame: Through study completion, an average of 3 months

    The time from disease onset to death, tracheostomy, or permanent assisted ventilation

Secondary outcomes

  1. Overall Survival

    Time frame: Through study completion, an average of 3 months

    Death owing to any causes

  2. Rate of Disease Progression

    Time frame: Through study completion, an average of 3 months

    (48-total ALSFRS-R)/symptom duration (months)

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Gao, MD, PhD

CONTACT

[email protected]

+86-10-84013209

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Acronym: CARE-TCM

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
May 13, 2021
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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