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.
Study Type
OBSERVATIONAL
Enrollment
328
The 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.
Time frame: From enrollment to week 48.
Annual Relapse Rate
Time frame: From enrollment to week 24 and week 48.
Proportion of Patients Without Relapse
Time frame: From enrollment to week 12, 24, 36, and 48.
Changes in EDSS Compared to Baseline
Time frame: From enrollment to week 12, 24, 36, and 48.
The proportion of patients with confirmed disability progression within 3 months.
Time frame: From enrollment to week 12, 24, 36, and 48.
The proportion of patients with confirmed disability progression within 6 months.
Time frame: From enrollment to week 24 and week 48.
Number of newly added gadolinium enhanced T1 lesions
Time frame: From enrollment to week 48.
Total number of gadolinium-enhanced T1 lesions
Time frame: From enrollment to week 48.
Changes in T1 lesion volume compared with baseline
Time frame: From enrollment to week 24 and week 48.
Number of newly added or enlargement gadolinium enhanced T2 lesions.
Time frame: From enrollment to week 24 and week 48.
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Changes in T2 lesion volume compared with baseline
Time frame: From enrollment to week 24 and week 48.
Proportion of patients with treatment interruption
Time frame: From enrollment to week 12, 24, 36, and 48.
Proportion of patients who terminated treatment
Time frame: From enrollment to week 12, 24, 36, and 48.
Proportion of patients who switch treatments
Time frame: From enrollment to week 12, 24, 36, and 48.