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| Name | Class |
|---|---|
| The Second Hospital of Hebei Medical University | OTHER |
| First Affiliated Hospital of Jinan University | OTHER |
| Chinese PLA General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMT group | RRMS patients receiving DMT. | ||
| YSDLY group | RRMS patients receiving DMT combining modified YSDLY formula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Yishen Daluo Yin formula | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks. | From enrollment to week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Relapse Rate | From enrollment to week 24 and week 48. | |
| Proportion of Patients Without Relapse | From enrollment to week 12, 24, 36, and 48. | |
| Changes in EDSS Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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This is a multicenter study, participants are from Beijing, Hebei, and Guangzhou.
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| From enrollment to week 12, 24, 36, and 48. |
| The proportion of patients with confirmed disability progression within 3 months. | From enrollment to week 12, 24, 36, and 48. |
| The proportion of patients with confirmed disability progression within 6 months. | From enrollment to week 24 and week 48. |
| Number of newly added gadolinium enhanced T1 lesions | From enrollment to week 48. |
| Total number of gadolinium-enhanced T1 lesions | From enrollment to week 48. |
| Changes in T1 lesion volume compared with baseline | From enrollment to week 24 and week 48. |
| Number of newly added or enlargement gadolinium enhanced T2 lesions. | From enrollment to week 24 and week 48. |
| Changes in T2 lesion volume compared with baseline | From enrollment to week 24 and week 48. |
| Proportion of patients with treatment interruption | From enrollment to week 12, 24, 36, and 48. |
| Proportion of patients who terminated treatment | From enrollment to week 12, 24, 36, and 48. |
| Proportion of patients who switch treatments | From enrollment to week 12, 24, 36, and 48. |