Relapse Remitting Multiple SclerosisNCT07029867
Efficacy and Safety of Yishen Daluo Yin Granule for Relapsing-Remitting Multiple Sclerosis
A study testing Yishen Daluo Yin granuls in people with Relapse Remitting Multiple Sclerosis, run by Ying Gao.
Trial summary
The aim of this study is to evaluate the efficacy and safety of YSDLY granule in patients with RRMS. This will be a multi-center, randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapse Remitting Multiple Sclerosis
- What is being tested?
- Yishen Daluo Yin granuls
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 31 Dec 2026
- Phase
- Interventional
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged 18 to 55 when signing the informed consent, 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), and neurological function remains stable.
- At least 1 relapse with evidence within two years prior to screening is required. This can be demonstrated by: a. Evidence of one relapse within one year prior to screening; b. At least one gadolinium-enhanced T1 lesion on MRI within the six months prior to screening.
- Participants with EDSS scores ranging from 0 to 5.5 at screening and baseline (Day 1) are eligible for inclusion. However, patients with an EDSS score of ≤ 2 at screening may only be included if their disease duration does not exceed 10 years.
- Women who were tested for fertility had negative results for pregnancy in their urine during the screening period, prior to the first day of medication.
- Signing the informed consent form, which the participant must fully understand, indicates that the individual has been provided with all pertinent information regarding the trial prior to enrollment and agrees to adhere to the protocol's requirements.
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 with an EDSS score of 2.0 or lower and a disease duration of more than 10 years during the screening process.
- Participants diagnosed with an immune system disease other than MS, or any other condition requiring oral, intravenous, or intramuscular corticosteroid medications, except for well-controlled type 2 diabetes or thyroid disease.
- Active and clinically significant viral, bacterial, tuberculosis, or fungal infections, as well as any severe acute infection that requires hospitalization or treatment with parenteral antibiotics within four weeks prior to screening; participants who have had close contact with patients suffering from infectious diseases, such as active tuberculosis; individuals who have tested positive for human immunodeficiency virus (HIV) either in the past or during screening; and those who have tested positive for hepatitis C virus (HCV) RNA or have a hepatitis B virus (HBV) DNA level of ≥ 10^6 copies/mL in the past or during screening.
- Participants with a history of any serious or life-threatening bleeding events, such as hemophilia, other coagulation disorders, or an international normalized ratio (INR) of 1.5 or greater, or an activated partial thromboplastin time (APTT) of 1.5 times the upper limit of the laboratory reference range (ULN), are excluded.
- Participants who have experienced an acute myocardial infarction or cerebrovascular disease within six months after screening, currently have active angina, or have a history of congestive heart failure that meets New York Heart Association (NYHA) Class III or IV criteria are excluded. Additionally, participants with long-term uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), those with electrocardiogram (ECG) abnormalities or any other significant active medical conditions that the researchers believe may affect their participation are also excluded.
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- There are other clinically significant abnormalities that researchers deem important, as well as major surgical procedures conducted within the two months preceding the screening.
- Participants have experienced episodes of severe depression within the six months prior to the screening, or are unable to complete this study due to mental illness, cognitive disorders, or emotional disorders.
- Participants with a history of cancer (unless cured>5 years), or any other illness with a life expectancy of less than 1 year.
- Pregnant or lactating women, or women of childbearing age who have a negative pregnancy test during screening but refuse to take effective contraceptive measures.
- Participants with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m², or those with any kidney disease that contraindicates the use of gadolinium, such as acute kidney injury. The formula for calculating eGFR is: eGFR = 186 × (blood creatinine)-¹.⁵⁴ × (age)-⁰.²⁰³ × (0.742 if female). The unit for blood creatinine is mg/dL, and the unit for age is years.
- ALT and AST levels greater than 2 times the upper limit of normal (ULN), total bilirubin levels exceeding 1.5 times the ULN, or any other clinically significant laboratory abnormalities.
- Significant reductions in blood cell counts, including a neutrophil count of less than 1,500/mm³, a platelet count of less than 75,000/mm³, an absolute lymphocyte count of less than 1,000/mm³, or a white blood cell count of less than 3,500/mm³.
- Participants who cannot performe MRI scans in certain situations include those with known allergic reactions to gadolinium contrast agents, individuals with pacemakers, or those with other contraindications.
- Individuals who are suspected or known to be allergic to the investigational drug or its ingredients should be excluded.
- Participants who have used any of the following medications in the four weeks prior to randomization are excluded: injections (including intravenous or intramuscular), oral corticosteroids, adrenocorticotropic hormone (ACTH), intravenous immunoglobulin, plasma exchange, immunoadsorption therapy, beta interferon, glatiramer acetate, or other fumarate esters such as diimidazole fumarate and dimethyl fumarate, as well as teriflunomide.
- Individuals who have previously used natalizumab or S1P receptor modulators (such as Fingolimod, Sinimod, Ozamod, etc.) in 12 weeks before randomization.
- Participants who have used any of the following pharmaceuticals or therapies within 48 weeks prior to randomization are excluded: dalizumab, BTK inhibitors, mitoxantrone, or lymphocyte depletion therapies (such as alemtuzumab, rituximab, ofatumumab, orelizumab, anti-CD4 preparations, cladribine, cyclophosphamide, azathioprine, systemic radiotherapy, bone marrow transplantation, or other therapies not explicitly listed).
- Dalfampridine or Fampridine can be used as adjuvant therapy if administered at stable doses in 12 weeks prior to randomization.
- Participants who have have participated in clinical trials of other investigational drugs within the past 48 weeks.
- Any situation that other researchers deem inappropriate for participation in this study.
About this study
Official title: Efficacy and Safety of Traditional Chinese Mecicine Yishen Daluo Yin Granule for Relapsing-remitting Multiple Sclerosis: A Randomized Controlled Trial
The aim of this study is to evaluate the efficacy and safety of YSDLY granule in patients with RRMS. This will be a multi-center, randomized, double-blind, placebo-controlled study.
- Conditions
- Relapse Remitting Multiple Sclerosis
- Being tested
- Yishen Daluo Yin granuls, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yishen Daluo Yin granulsDrug
The patient takes YSDLY granules or placebo twice a day.
PlaceboDrug
The patient takes placebo (YSDL mimetic granules) twice a day.
| Study group | Role | What they receive |
|---|---|---|
| YSDLY group | Experimental | RRMS patients received YSDLY granuls. Receives: Drug: Yishen Daluo Yin granuls |
| Placebo group | Placebo comparator | RRMS patients received placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients without combined unique active lesions (CUALs) in 24W compared to baseline.
The proportion of patients without combined unique active lesions (CUALs) at 24 weeks compared to baseline. CUALs refer to newly identified gadolinium-enhanced T1 lesions or newly added or expanded T2 lesions that are not counted repeatedly.
Measured: From enrollment to the end of treatment at 24 weeks.
Secondary outcomes (7)
Average Relapse Time
Measured: From enrollment to the end of treatment at 24 weeks.
Annual Relapse Rate
Measured: From enrollment to week 12 and 24.
Proportion of Patients Without Relapse
Measured: From enrollment to week 12 and 24.
Changes in Expanded Disability Status Scale (EDSS) Compared to Baseline. A score of 0 on the scale indicates the absence of clinical symptoms, while a score of 10 represents death resulting from illness.
Measured: From enrollment to week 12 and 24.
Number of newly added gadolinium enhanced T1 lesions compared to baseline.
Measured: From enrollment to week 12 and 24.
Number of newly added or expanded T2 lesions compared to baseline.
Measured: From enrollment to week 12 and 24.
Changes in T2 lesion volume compared with baseline
Measured: From enrollment to week 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Mar 2026 (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 Relapse Remitting Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Gao
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University, The Second Hospital of Hebei Medical University, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029867
- Sponsor's protocol ID
- 2024DZMEC-604
- Status last verified
- May 2025
- First submitted
- 9 Jun 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No