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Not yet recruiting NCT07037823

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

— Observational RRMS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modified Yishen Daluo Yin formula.
Who it may be relevant to
Registry conditions: RRMS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Primary outcome measures

  • The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks. [Time frame: From enrollment to week 48.]
Secondary outcome measures (12)
  • Annual Relapse Rate [Time frame: From enrollment to week 24 and week 48.]
  • Proportion of Patients Without Relapse [Time frame: From enrollment to week 12, 24, 36, and 48.]
  • Changes in EDSS Compared to Baseline [Time frame: From enrollment to week 12, 24, 36, and 48.]
  • The proportion of patients with confirmed disability progression within 3 months. [Time frame: From enrollment to week 12, 24, 36, and 48.]
  • The proportion of patients with confirmed disability progression within 6 months. [Time frame: From enrollment to week 24 and week 48.]
  • Number of newly added gadolinium enhanced T1 lesions [Time frame: From enrollment to week 48.]
  • Total number of gadolinium-enhanced T1 lesions [Time frame: From enrollment to week 48.]
  • Changes in T1 lesion volume compared with baseline [Time frame: From enrollment to week 24 and week 48.]
  • Number of newly added or enlargement gadolinium enhanced T2 lesions. [Time frame: From enrollment to week 24 and week 48.]
  • Changes in T2 lesion volume compared with baseline [Time frame: From enrollment to week 24 and week 48.]
  • Proportion of patients with treatment interruption [Time frame: From enrollment to week 12, 24, 36, and 48.]
  • Proportion of patients who terminated treatment [Time frame: From enrollment to week 12, 24, 36, and 48.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07037823 · 2024DZMEC-605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗