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NCT07037823

Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis

Sponsor: Ying Gao

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

328

Start Date

2025-07-01

Completion Date

2026-12-31

Last Updated

2025-06-26

Healthy Volunteers

Conditions

RRMS

Interventions

OTHER

Modified 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.

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.