Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
1 other identifier
observational
2,000
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2030
June 13, 2022
June 1, 2022
7.4 years
June 9, 2022
June 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized Aggregate Relapse Rate (ARR)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The ARR was the mean of the annualized ARRs for all patients, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Baseline up to 5 years
Secondary Outcomes (12)
Total Number of Adverse Events During Evaluation
Baseline up to 5 years
Percentage of Participants With Adverse Events
Baseline up to 5 years
Time to 3-month Sustained Disability Progression
5 years
Time to 6-month Sustained Disability Progression
5 years
Number of New or Newly Enlarging T2 hyperintense lesions as Measured by Magnetic Resonance Imaging (MRI)
From baseline to 12 months, 24 months, 36 months, 48 months, 60 months
- +7 more secondary outcomes
Study Arms (1)
DDC patients with Traditional Chinese medicine (TCM) treatment
TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong. This study does not limit Western medical treatment methods. Patients commonly applied high dose of intravenous steroid treatment in the acute phase, which usually referred to intravenous administration of 1g or 500mg of glucocorticoid daily for 3 consecutive days and reduced by half every 3 days. In addition, plasma exchange and immunoabsorption are also optional treatment for the acute phase. Immunomodulatory therapies including low dose of steroid, immunosuppressants (Azathioprine, Mycophenolate, etc.), and disease-modifying therapy (fingolimod, Teriflunomide, Rituximab, Satralizumab, etc.) are necessary for the remission phase.
Interventions
TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.
Eligibility Criteria
DATE-TCM includes all patients with Demyelinating Diseases of the Central Nervous System at beginning of study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 13, 2022
Study Start
June 20, 2022
Primary Completion (Estimated)
October 31, 2029
Study Completion (Estimated)
May 31, 2030
Last Updated
June 13, 2022
Record last verified: 2022-06