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

ConditionRRMS
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYing Gao

About this trial

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.

Eligibility criteria

Qualifiers

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).)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Modified Yishen Daluo Yin formula

Treatment groups

328 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ying Gao

Lead sponsor

Dongzhimen Hospital, Beijing

Sponsor institution

The Second Hospital of Hebei Medical University

Collaborator

First Affiliated Hospital of Jinan University

Collaborator

Chinese PLA General Hospital

Collaborator