Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Traditional Chinese medicine (TCM).
- Who it may be relevant to
- Registry conditions: Demyelinating Diseases of the Central Nervous System (DDC). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) is an observational study aiming to better define the multidimensional (epidemiologic, demographic and clinical) characteristics of Demyelinating Diseases of the Central Nervous System (DDC) patients receiving Traditional Chinese medicine (TCM) treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.
Detailed description
Demyelinating Diseases of the Central Nervous System (DDC) is a collective term for a group of immune-mediated disorders including multiple sclerosis, Neuromyelitis optica spectrum disorder, and myelin oligodendrocyte glycoprotein associated disorder, characterized by myelin loss and axonal damage in the central nervous system. Traditional Chinese medicine (TCM), a main form of complementary and alternative medicine provides a potential possibility to DDC management and has been applied to a considerable number of patients with this disorder in China as well as in other regions or countries worldwide. Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) provides a prospective and voluntary registry aiming to include 2000 eligible adult DDC patients with TCM intervenes from around 30 participating centers by using a web-based system. Baseline data will be recorded and subsequently regular follow-up visits will be implemented every 3-6 months for a total of 5 years. Main objective of DATE-TCM is to create an organized multicenter structure to collect reliable data for better define the multidimensional (epidemiologic, demographic and clinical) characteristics of DDC patients receiving TCM treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.
Interventions
- Other Traditional Chinese medicine (TCM)
TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.
Primary outcome measures
- Annualized Aggregate Relapse Rate (ARR) [Time frame: Baseline up to 5 years]
Secondary outcome measures (12)
- Total Number of Adverse Events During Evaluation [Time frame: Baseline up to 5 years]
- Percentage of Participants With Adverse Events [Time frame: Baseline up to 5 years]
- Time to 3-month Sustained Disability Progression [Time frame: 5 years]
- Time to 6-month Sustained Disability Progression [Time frame: 5 years]
- Number of New or Newly Enlarging T2 hyperintense lesions as Measured by Magnetic Resonance Imaging (MRI) [Time frame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months]
- Number of Gadolinium-enhancing T1-weighted Lesions as Measured by Magnetic Resonance Imaging (MRI) [Time frame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months]
- Percent Change in Brain Volume Measured by Magnetic Resonance Imaging (MRI) [Time frame: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months]
- Change in Multiple Sclerosis Functional Composite (MSFC) score [Time frame: Every 6 months up to 5 years]
- Change in Symbol Digit Modalities Test (SDMT) score [Time frame: Every 6 months up to 5 years]
- Chance in fatigue severity scale (FSS) score [Time frame: Every 6 months up to 5 years]
- Change in EuroQol- 5 Dimension (EQ-5D) score [Time frame: Every 6 months up to 5 years]
- Change from Multiple Sclerosis impact scale (MSIS) score [Time frame: Every 6 months up to 5 years]
Eligibility criteria
Inclusion criteria
- Male or female participants with aged 18-65 years old; Diagnosis of DDC including multiple sclerosis (MS), Neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein-associated disease(MOGAD) according to relevant criteria or consensus; Patients who receive or are willing to receive TCM treatment including the Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong; Informed written consent obtained from the patient, and/or his/her legally authorized representatives.
Exclusion criteria
- Refusal to give informed consent; Malignancies, infectious diseases (HBV, HCV, HIV, etc.), congenital or acquired severe immunodeficiency, significant cardiovascular, pulmonary, and hepatic diseases or conditions; Mental disturbance or severe cognitive impairment impeding necessary information gathering and assessment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05415579 · DDCR-TCM-2022