NCT07037823尚未招募不适用
Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis: A Prospective Multi-Center Observational Comparative Study
Ying Gao0 个研究点目标入组 328 人开始时间: 2025年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 328
- 主要终点
- The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).)
- •Signing the informed consent form.
- •Participants were able to engage in clinical follow-up throughout the entire study period.
排除标准
- •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.
- •Pregnant or lactating women.
- •Patients who are currently receiving or participating in other immunosuppressive, immunomodulatory, MS DMT treatment or clinical trials.
- •Any situation that other researchers deem inappropriate for participation in this study.
结局指标
主要结局
The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks.
时间窗: From enrollment to week 48.
次要结局
- 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.)
- 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.)
- 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(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.)
研究者
Ying Gao
Professior
Dongzhimen Hospital, Beijing
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