NCT05415579

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Demyelinating Diseases of the Central Nervous System (DDC)

Interventions

Type	Name	Description
OTHER	Traditional Chinese medicine (TCM)	TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.

Timeline

• Start date: 2022-06-20
• Primary completion: 2029-10-31
• Completion: 2030-05-31
• First posted: 2022-06-13
• Last updated: 2022-06-13