RRMSNCT07037823
Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis
An observational study of RRMS, run by Ying Gao.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RRMS
- What is being tested?
- Modified Yishen Daluo Yin formula
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a multicenter study, participants are from Beijing, Hebei, and Guangzhou.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- Modified Yishen Daluo Yin formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Yishen Daluo Yin formulaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| DMT group | RRMS patients receiving DMT. | |
| YSDLY group | RRMS patients receiving DMT combining modified YSDLY formula. Receives: Other: Modified Yishen Daluo Yin formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks.
Measured: From enrollment to week 48.
Secondary outcomes (13)
Annual Relapse Rate
Measured: From enrollment to week 24 and week 48.
Proportion of Patients Without Relapse
Measured: From enrollment to week 12, 24, 36, and 48.
Changes in EDSS Compared to Baseline
Measured: From enrollment to week 12, 24, 36, and 48.
The proportion of patients with confirmed disability progression within 3 months.
Measured: From enrollment to week 12, 24, 36, and 48.
The proportion of patients with confirmed disability progression within 6 months.
Measured: From enrollment to week 24 and week 48.
Number of newly added gadolinium enhanced T1 lesions
Measured: From enrollment to week 48.
Total number of gadolinium-enhanced T1 lesions
Measured: From enrollment to week 48.
Changes in T1 lesion volume compared with baseline
Measured: From enrollment to week 24 and week 48.
Number of newly added or enlargement gadolinium enhanced T2 lesions.
Measured: From enrollment to week 24 and week 48.
Changes in T2 lesion volume compared with baseline
Measured: From enrollment to week 24 and week 48.
Proportion of patients with treatment interruption
Measured: From enrollment to week 12, 24, 36, and 48.
Proportion of patients who terminated treatment
Measured: From enrollment to week 12, 24, 36, and 48.
Proportion of patients who switch treatments
Measured: From enrollment to week 12, 24, 36, and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RRMSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Gao
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, First Affiliated Hospital of Jinan University, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037823
- Sponsor's protocol ID
- 2024DZMEC-605
- Status last verified
- May 2025
- First submitted
- 9 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07037823
- Acronym / sponsor ID
- 2024DZMEC-605
- Conditions
- RRMS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Ying GaoUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, First Affiliated Hospital of Jinan University, Chinese PLA General Hospital
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMT group | – | –RRMS patients receiving DMT. |
| YSDLY group | – | Other: Modified Yishen Daluo Yin formulaRRMS patients receiving DMT combining modified YSDLY formula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter study, participants are from Beijing, Hebei, and Guangzhou.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Yishen Daluo Yin formulaThe 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. | Other | YSDLY group |
Primary outcome
The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks.
Time frame: From enrollment to week 48.
13 secondary outcomes
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.
Proportion of patients who switch treatments
Time frame: From enrollment to week 12, 24, 36, and 48.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of RRMS, run by Ying Gao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks. (time frame: From enrollment to week 48.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.