Clinical Trial of Huoluo Pills Combined With Iguratimod T... | NCT07115641

NCT07115641

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
ITMCTR2025000953	Other Identifier	ITMCTR
MR-11-25-036909	Other Identifier	China National Medical Research Registration and Filing Information System

Status Module

Name	Class
Institute of Science, Beijing Tongrentang Co., Ltd.	UNKNOWN
Beijing Leadingpharm Medicine Technology Development	UNKNOWN
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Description Module

Label	Type	Description	Intervention Names
Trial group	Experimental	Huoluo Pills + Iguratimod Tablets	Drug: Huoluo Pills Drug: Iguratimod Tablets
Control group	Other	Iguratimod Tablets	Drug: Iguratimod Tablets

Name	Type	Description	Arm Group Labels	Other Names
Huoluo Pills	Drug	Huoluo Pills: Orally take 1 pill once, twice a day (swallow with warm water)	Trial group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of subjects achieving ACR20	ACR20: The improvement degree of the number of tender joints and the number of swollen joints is ≥20%, and the improvement degree of at least 3 items among the remaining 5 items is ≥20%.	At the end of the treatment (on the 84th day)

Secondary Outcomes

Measure	Description	Time Frame
The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline	DAS28-CRP=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.36×ln（CRP+1）+0.014×GH+0.96 TJC28: Number of tender joints among 28 joints; SJC28: Number of swollen joints among 28 joints; ESR: Erythrocyte Sedimentation Rate; CRP: C-reactive Protein; GH: Patient's global assessment of disease activity (VAS score, unit: 100mm). Disease activity DAS28-CRP thresholds: High: > 4.1; Moderate: > 2.7 and ≤ 4.1; Low: > 2.3 and ≤ 2.7; Remission: ≤ 2.3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who meet the Western medicine classification criteria for rheumatoid arthritis (RA) launched by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2010 and have been clearly diagnosed with RA.
Subjects who meet the diagnostic criteria for traditional Chinese medicine syndromes of "Wind-Dampness Obstruction Syndrome (Main symptoms: ① Joint pain and swelling wandering; ② Joint pain and swelling intermittent. Secondary symptoms: ① Aversion to wind or sweating; ② Headache; ③ Heaviness of the limbs. Tongue and pulse manifestations: Pale red tongue thin white coating slippery or floating pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)" or "Cold-Dampness Obstruction Syndrome (Main symptoms: ① Cold joint pain the joints feel cold to the touch and the skin color is not red; ② The pain worsens when exposed to cold and alleviates when warmed. Secondary symptoms: ① Joint stiffness limited flexion and extension; ② Cold limbs or aversion to cold and preference for warmth; ③ Bland taste in the mouth without thirst. Tongue and pulse manifestations: Enlarged tongue body pale tongue white or greasy coating wiry or tight pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)".
Subjects with a Disease Activity Score in 28 joints (DAS28) (ESR) score > 2.6 and ≤ 5.1 or a DAS28 (CRP) score > 2.3 and ≤ 4.1.
Male or female subjects aged ≥ 18 years old and ≤ 70 years old.
Subjects who have not used iguratimod and Huoluo Pills within 4 weeks before the first administration of the investigational drug.
If the subject is receiving treatment with traditional disease-modifying antirheumatic drugs (DMARDs) during screening monotherapy with one of methotrexate (MTX) leflunomide or hydroxychloroquine is allowed and the dosage should be stable for at least 12 weeks before the first administration of the investigational drug (MTX dosage ≤ 15 mg/week leflunomide ≤ 20 mg/day hydroxychloroquine ≤ 400 mg/day).
Subjects who are receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs) during screening should have a stable dosage for at least 2 weeks before the first administration of the investigational drug and maintain the same dosage during the trial.
Subjects who are receiving hormone treatment during screening should have a stable condition (limited to oral administration of ≤ 10 mg/d prednisone acetate or equivalent dose) for at least 4 weeks before the first administration of the investigational drug and maintain stable treatment during the trial.
Subjects who voluntarily agree to participate in this trial sign a written informed consent form are able to follow the visit and related procedures specified in the protocol and have good compliance.

Exclusion Criteria:

Those who have used plant medicine preparations such as Tripterygium glycosides total glucosides of paeony sinomenine or other traditional Chinese medicine preparations that affect the evaluation of the therapeutic effect within 4 weeks before the first administration of the test drug;
Those who have received intramuscular injection intravenous injection or intra-articular injection of glucocorticoid treatment within 4 weeks before the first administration of the test drug;
Patients who have received treatment with biological agents within 12 weeks before the first administration of the test drug;
Those who suffer from active gastrointestinal diseases (such as peptic ulcers) severe interstitial lung diseases low bone marrow function severe cardiovascular and cerebrovascular diseases (such as acute myocardial infarction unstable angina pectoris intracerebral hemorrhage transient ischemic attack) severe organic lesions such as poorly controlled diabetes mellitus or those who have a history of malignant tumors in the past 5 years or those with mental illnesses. ;
Those known to have tuberculosis HIV hepatitis B hepatitis C syphilis or other active or chronic persistent infections;
Those who are allergic to the drugs involved in the research protocol or have contraindications to their use;
Those who have received live vaccines within 4 weeks before screening or inactivated vaccines within 2 weeks before screening or those who have a vaccination plan during the trial;
Those with any of the following conditions in the auxiliary examination during screening: 1) AST or ALT > 1.5 times the upper limit of the normal reference value or the estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m²; 2) Hemoglobin < 90 g/L or white blood cell count < 3.0×10⁹/L or neutrophil count < 1.5×10⁹/L or lymphocyte count < 0.5×10⁹/L or platelet count < 90×10⁹/L;
Pregnant or lactating women those with a fertility plan or those planning to donate sperm or eggs;
Those who are participating in other clinical trials before screening;
Those whom the investigator deems to have other factors that make them unsuitable to participate in this trial.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases