This study aims to systematically evaluate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of rheumatoid arthritis (RA). A total of 240 patients with RA belonging to the syndromes of Wind - Damp Obstruction or Cold - Damp Obstruction will be enrolled in 8 centers (randomly assigned to groups). The experimental group will receive oral Huoluo Pills combined with Iguratimod Tablets, while the control group will receive oral Iguratimod Tablets alone. Both groups will be administered continuously for 12 weeks.
Primary Efficacy Index: The proportion of ACR20 responders in each group at the end of treatment.
Key Secondary Efficacy Index: The change in DAS28 (CRP) score from baseline in each group at the end of treatment.
Other Secondary Efficacy Indexes: RF, CRP, ESR, IL - 6, ACR50, ACR70, CDAI, SDAI, HAQ - DI, SF - 36, FACIT - Fatigue, and Traditional Chinese Medicine (TCM) syndrome scores.
Safety Indexes: Physical examination, blood routine, urine routine, blood biochemistry, coagulation function, etc.
This study will investigate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of RA with Wind - Damp Obstruction or Cold - Damp Obstruction syndromes.
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.
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. ;
Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead sponsor
Institute of Science, Beijing Tongrentang Co., Ltd.
Collaborator
Beijing Leadingpharm Medicine Technology Development
Collaborator
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Henan university of CM
Collaborator
Xi'an No.5 Hospital
Collaborator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Shaanxi Hospital of Traditional Chinese Medicine
Collaborator