Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)

Dongzhimen Hospital, Beijing

Status: Not yet enrolling

Conditions: Demyelinating Diseases of the Central Nervous System (DDC)

Treatments: Other: Traditional Chinese medicine (TCM)

Study type: Observational

Funder types: Other

Identifiers

NCT05415579

DDCR-TCM-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

DDC patients with Traditional Chinese medicine (TCM) treatment

Description:

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.

Treatment:

Other: Traditional Chinese medicine (TCM)