RRMS
Conditions
Brief summary
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.
Interventions
OTHERModified Yishen Daluo Yin formula
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.
Sponsors
The Second Hospital of Hebei Medical University
First Affiliated Hospital of Jinan University
Chinese PLA General Hospital
Ying Gao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants who are over 18 years old at the time of signing the informed consent form, with no gender restrictions. 2. 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. 3. No clinical relapse, as defined in the protocol, has occurred for 30 days or more prior to screening and baseline (Day 1). 4. 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).) 5. Signing the informed consent form. 6. Participants were able to engage in clinical follow-up throughout the entire study period.
Exclusion criteria
1. 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. 2. Participants who cannot performe MRI scans in certain situations include individuals with known allergic reactions to gadolinium contrast agents or those with other contraindications. 3. The expected lifespan is less than one year. 4. Participants who cannot complet the study due to mental illness, cognitive or emotional disorders. 5. Pregnant or lactating women. 6. Patients who are currently receiving or participating in other immunosuppressive, immunomodulatory, MS DMT treatment or clinical trials. 7. Any situation that other researchers deem inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks. | From enrollment to week 48. |
Secondary
| Measure | 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 | 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. |
| Changes in T2 lesion volume compared with baseline | From enrollment to week 24 and 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. |
| 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. |
| Total number of gadolinium-enhanced T1 lesions | From enrollment to week 48. |
Outcome results
None listed