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

NCT ID: NCT07037823

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 328 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-31

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.

Conditions

RRMS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DMT group

RRMS patients receiving DMT.

No interventions assigned to this group

YSDLY group

RRMS patients receiving DMT combining modified YSDLY formula.

Modified Yishen Daluo Yin formula

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Ying Gao

OTHER

Sponsor Role: lead

Responsible Party

Ying Gao

Professior

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2024DZMEC-605

Identifier Type: -

Identifier Source: org_study_id