This study was designed to investigate the effectiveness of a combined strategy utilizing disease-modifying therapy and the modified Yishen Daluo Yin formula for relapsing-remitting multiple sclerosis (RRMS) through a prospective, multicenter, observational comparative study.
Participants who are over 18 years old at the time of signing the informed consent form, with no gender restrictions.
Participants meet the diagnostic criteria for multiple sclerosis (MS) as outlined in the 2017 McDonald's diagnostic criteria and the 2023 edition of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Sclerosis.
No clinical relapse, as defined in the protocol, has occurred for 30 days or more prior to screening and baseline (Day 1).
Patients receiving first-line DMT drug treatment at a stable dosage. (The first-line DMT drugs involved in this study have stable dosages: Teriflunomide (14 mg, oral, once daily), Dimethyl Fumarate (240 mg, oral, twice daily), Fingolimod Hydrochloride (0.5 mg, oral, once daily), Siponimod (1 mg or 2 mg daily), Ozanimod (0.92 mg, oral, once daily), Ofatumumab (20 mg, subcutaneous injection once every 28 days), and Glatiramer Acetate (20 mg, subcutaneous injection once daily or 40 mg, three times a week).)
According to the 2017 McDonald's guidelines and the 2023 version of the Chinese Multiple Sclerosis Diagnosis and Treatment Guidelines, individuals diagnosed with progressive MS, including both primary progressive MS (PPMS) and secondary progressive MS (SPMS), are excluded.
Participants who cannot performe MRI scans in certain situations include individuals with known allergic reactions to gadolinium contrast agents or those with other contraindications.
The expected lifespan is less than one year.
Participants who cannot complet the study due to mental illness, cognitive or emotional disorders.
This is a multicenter study, participants are from Beijing, Hebei, and Guangzhou.
Cohort
Prospective
Modified Yishen Daluo Yin formula
Other interventionThe specific application of the modified Yishen Daluo Yin formula, including the starting point, dosage, and duration of treatment, should be determined based on medical advice, the patient's condition, and their individual preferences.
The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks.
Annual Relapse Rate
Proportion of Patients Without Relapse
Changes in EDSS Compared to Baseline
The proportion of patients with confirmed disability progression within 3 months.
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Ying Gao
Lead sponsor
Dongzhimen Hospital, Beijing
Sponsor institution
The Second Hospital of Hebei Medical University
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Chinese PLA General Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
