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.
Participants aged 18 to 55 when signing the informed consent, 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), and neurological function remains stable.
At least 1 relapse with evidence within two years prior to screening is required. This can be demonstrated by: a. Evidence of one relapse within one year prior to screening; b. At least one gadolinium-enhanced T1 lesion on MRI within the six months prior to screening.
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 with an EDSS score of 2.0 or lower and a disease duration of more than 10 years during the screening process.
Participants diagnosed with an immune system disease other than MS, or any other condition requiring oral, intravenous, or intramuscular corticosteroid medications, except for well-controlled type 2 diabetes or thyroid disease.
Active and clinically significant viral, bacterial, tuberculosis, or fungal infections, as well as any severe acute infection that requires hospitalization or treatment with parenteral antibiotics within four weeks prior to screening; participants who have had close contact with patients suffering from infectious diseases, such as active tuberculosis; individuals who have tested positive for human immunodeficiency virus (HIV) either in the past or during screening; and those who have tested positive for hepatitis C virus (HCV) RNA or have a hepatitis B virus (HBV) DNA level of ≥ 10^6 copies/mL in the past or during screening.
Parallel
Yishen Daluo Yin granuls
DrugThe patient takes YSDLY granules or placebo twice a day.
Placebo
DrugThe patient takes placebo (YSDL mimetic granules) twice a day.
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.
Average Relapse Time
Annual Relapse Rate
Proportion of Patients Without Relapse
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.
Changes in the level of neurofilament light chain (NFL) compared to the baseline
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.
Changes in the EuroQol Five Dimensions (EuroQol-5D) scale scores compared to the baseline. The higher the score, the better the quality of life.
Changes in TCM syndrome compared to baseline.
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Ying Gao
Lead sponsor
Dongzhimen Hospital, Beijing
Sponsor institution
First Affiliated Hospital of Jinan University
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Chinese PLA General Hospital
Collaborator
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