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NCT Number: NCT07037823

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From enrollment to week 48.

Secondary outcomes

  1. Annual Relapse Rate

    Time frame: From enrollment to week 24 and week 48.

  2. Proportion of Patients Without Relapse

    Time frame: From enrollment to week 12, 24, 36, and 48.

  3. Changes in EDSS Compared to Baseline

    Time frame: From enrollment to week 12, 24, 36, and 48.

  4. The proportion of patients with confirmed disability progression within 3 months.

    Time frame: From enrollment to week 12, 24, 36, and 48.

  5. The proportion of patients with confirmed disability progression within 6 months.

    Time frame: From enrollment to week 24 and week 48.

  6. Number of newly added gadolinium enhanced T1 lesions

    Time frame: From enrollment to week 48.

  7. Total number of gadolinium-enhanced T1 lesions

    Time frame: From enrollment to week 48.

  8. Changes in T1 lesion volume compared with baseline

    Time frame: From enrollment to week 24 and week 48.

  9. Number of newly added or enlargement gadolinium enhanced T2 lesions.

    Time frame: From enrollment to week 24 and week 48.

  10. Changes in T2 lesion volume compared with baseline

    Time frame: From enrollment to week 24 and week 48.

  11. Proportion of patients with treatment interruption

    Time frame: From enrollment to week 12, 24, 36, and 48.

  12. Proportion of patients who terminated treatment

    Time frame: From enrollment to week 12, 24, 36, and 48.

  13. Proportion of patients who switch treatments

    Time frame: From enrollment to week 12, 24, 36, and 48.

Sponsors and collaborators

Lead sponsor

Ying Gao

Other

Collaborators

  • Chinese PLA General Hospital
  • First Affiliated Hospital of Jinan University
  • The Second Hospital of Hebei Medical University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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