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

NCT07037823 | Not Yet Recruiting DMC

• 1 other identifier: 2024DZMEC-605
• Study Type: observational
• Target: 328
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks.

  From enrollment to week 48.

Secondary Outcomes (13)

• 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.

Study Arms (2)

DMT group

RRMS patients receiving DMT.

YSDLY group

RRMS patients receiving DMT combining modified YSDLY formula.

Other: Modified Yishen Daluo Yin formula

Interventions

Modified Yishen Daluo Yin formula 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.

YSDLY group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a multicenter study, participants are from Beijing, Hebei, and Guangzhou.

You may qualify if:

• 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).)
• Signing the informed consent form.
• Participants were able to engage in clinical follow-up throughout the entire study period.

You may not qualify if:

• 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.
• Pregnant or lactating women.
• Patients who are currently receiving or participating in other immunosuppressive, immunomodulatory, MS DMT treatment or clinical trials.
• Any situation that other researchers deem inappropriate for participation in this study.

Sponsors & Collaborators

• Ying Gao: lead
• The Second Hospital of Hebei Medical University: collaborator
• First Affiliated Hospital of Jinan University: collaborator
• Chinese PLA General Hospital: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professior

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share