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Not yet recruitingNCT07037823Updated Jun 26, 2025

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

An observational study in RRMS, sponsored by Ying Gao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Ying Gao · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
328
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • RRMS
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In context

Lead sponsor

Ying Gao is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
328 participants (estimated)
Patient registry
No

Groups and cohorts

  • DMT group

    RRMS patients receiving DMT.

  • YSDLY group

    RRMS patients receiving DMT combining modified YSDLY formula.

    Other: Modified Yishen Daluo Yin formula

Interventions

  • OtherModified 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.

06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07037823
Lead sponsor
Ying Gao
Collaborators
The Second Hospital of Hebei Medical University, First Affiliated Hospital of Jinan University, Chinese PLA General Hospital
Responsible party
Ying Gao (Professior, Dongzhimen Hospital, Beijing) — Sponsor-investigator
First posted
Jun 26, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 26, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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