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| Name | Class |
|---|---|
| First Affiliated Hospital of Jinan University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| Chinese PLA General Hospital | OTHER |
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The aim of this study is to evaluate the efficacy and safety of YSDLY granule in patients with RRMS. This will be a multi-center, randomized, double-blind, placebo-controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YSDLY group | Experimental | RRMS patients received YSDLY granuls. |
|
| Placebo group | Placebo Comparator | RRMS patients received placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yishen Daluo Yin granuls | Drug | The patient takes YSDLY granules or placebo twice a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients without combined unique active lesions (CUALs) in 24W compared to baseline. | The proportion of patients without combined unique active lesions (CUALs) at 24 weeks compared to baseline. CUALs refer to newly identified gadolinium-enhanced T1 lesions or newly added or expanded T2 lesions that are not counted repeatedly. | From enrollment to the end of treatment at 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Relapse Time | From enrollment to the end of treatment at 24 weeks. | |
| Annual Relapse Rate | From enrollment to week 12 and 24. | |
| Proportion of Patients Without Relapse |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the level of neurofilament light chain (NFL) compared to the baseline | From enrollment to week 12 and 24. | |
| Changes in the multiple sclerosis quality of life questionnaire (MSQol-54) scale scores compared to the baseline. The MSQOL-54 scale has a total score range of 0 to 100 points, with higher scores indicating a better quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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| Placebo |
| Drug |
The patient takes placebo (YSDL mimetic granules) twice a day. |
|
| From enrollment to week 12 and 24. |
| Changes in Expanded Disability Status Scale (EDSS) Compared to Baseline. A score of 0 on the scale indicates the absence of clinical symptoms, while a score of 10 represents death resulting from illness. | From enrollment to week 12 and 24. |
| Number of newly added gadolinium enhanced T1 lesions compared to baseline. | From enrollment to week 12 and 24. |
| Number of newly added or expanded T2 lesions compared to baseline. | From enrollment to week 12 and 24. |
| Changes in T2 lesion volume compared with baseline | From enrollment to week 12 and 24. |
| From enrollment to the end of the treatment at 24 weeks. |
| Changes in the EuroQol Five Dimensions (EuroQol-5D) scale scores compared to the baseline. The higher the score, the better the quality of life. | From enrollment to the end of treatment at 24 weeks. |
| Changes in TCM syndrome compared to baseline. | From enrollment to week 4, 8, 12, 16, 20, and 24. |