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

Launched by YING GAO · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether combining standard disease-modifying therapies (DMTs) with a traditional herbal formula called the modified Yishen Daluo Yin can help people with relapsing-remitting multiple sclerosis (RRMS). RRMS is a type of multiple sclerosis where symptoms come and go in episodes. The goal is to see if this combination approach works better than the usual treatment alone. The study will observe and compare patients over time to gather information about how well this combined treatment works.

People who may join the study need to be adults diagnosed with RRMS according to accepted guidelines, with no recent flare-up of symptoms for at least 30 days before starting. They must already be on a stable dose of certain approved MS medications and be willing to follow the study plan and attend check-ups. The study is open to all genders but does not include people with progressive forms of MS, those who cannot have MRI scans, pregnant or breastfeeding women, or those currently in other MS treatment trials. Participants can expect regular monitoring to see how the treatments affect their condition. This study is not yet recruiting, but it aims to provide helpful information for improving MS care in the future.

Gender

ALL

Eligibility criteria

• 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.