None listed
Conditions
Interventions
Drug : Patients assigned to Experimental group (Geonchildan group) take one capsule of Geonchildan three times per day for 12 weeks.
Patients assigned to Control group (placebo group) take one capsul
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females with 19-75 years of age 2. Subjects who were diagnosed with Rheumatoid arthritis according to the 2010 ACR/EULAR(American College of Rheumatology/European League Against Rheumatism) classification criteria and had RA for at least 3 months 3. Subjects with active rhuematoid arthiritis [Disease activity score in 28 joints (DAS28) = 3.2] 4. Subjects who had received one anti-rheumatic drug(methotrexate:MTX) for more than 3 months. The amount dose of methotrexate had to be maintained at least during 8 weeks before participation of trial. (7.5~25 mg/week oral or equivalent injection dose) 5. Subjects who had at least three swollen joints and three tender joints 6. Subjects who decided to participate in clinical trials and singed a consent form voluntarily or by legal representative after providing with detailed explanation about object and characteristics of this clinical trial
Exclusion criteria
Exclusion criteria: 1. Subjects who had at least one of following laboratory abnormalities at screening White blood cells = 3,000/mm3 Hemoglobin < 8.5g/dL Platelet count <100,000/mm3 Serum creatinine> 2.0mg/dL Aspartate transminase(AST) or Alanine transaminase(ALT) = 2 times of upper limit of normal range 2. Subjects determined by researchers that operation corresponding to evaluation joint affects clinical trial's results or surgical procedure is planned or necessary. 3. Subjects who had severe infections including major respiratory diseases or received systematic antibiotics within 2 weeks 4. Subjects who had clinically uncontrolled cardiovascular disease 5. Subjects who had a history of malignancy within 5 years (However, subjects who have history of completely treated nonmelanoma skin cancer or uterine cervical cancer can be included) 6. Subjects with autoimmune disease except rheumatoid arthritis 7. Subjects who had a history of severe hypersensitivity or allergic reaction to investigative drug and same ingredient (for example, poison ivy dermatitis) 8. Subjects who received investigative drugs of another clinical study within 3 months of screening 9. Subjects who had medically and psychologically contraindications about investigative drug 10. Subjects who are pregnant, planning to be pregnant, or breast-feeding during the clinical trial 11. Subjects who is difficult to move voluntarily with high disease activity or unsuitable for study inclusion in the investigator's judgement 12. Applicable for the followings - Subjects who got steroid injection into glenoid cavity of evaluation joint within 4 weeks of screening - Subjects who got oral steroids more 10 mg per day or newly within 4 weeks of screening or changed dose of steroids within 2 weeks of screening - Subjects who got nonsteroidal anti-inflammatroy drugs(NSAIDs) newly within 4 weeks of screening or changed dose of NSAIDs within 2 weeks of screening - Subjects who got biological medicines or cell proliferation inhibitors before screening - Subjects who started new anti-rheumatic drugs within 4 weeks of screening or needed change of dose of prescribed anti-rheumatic drugs during clinical trial periods 13. Subjects who are treated for liver disease or kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in DAS28(Disease activity score in 28 joints) scores | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving American College of Rheumatology 20 response rates (ACR20), American College of Rheumatology 50 response rates (ACR50), American College of Rheumatology 70 response rates (ACR70);The proportion of EULAR(European League Against Rheumatism) response (disease remission, good or moderate);The changes in DAS28 item scores;The dose of oral corticosteroids and nonsteroidal anti-inflammatory drugs;The change in K-HAQ(Korean Health Assessment Questionnaire) scores;The laboratory parameters(inflammatory markers);The Korean medical diagnostic pattern indicator (Blood stasis pattern);Vital sign;Physical examination;Laboratory experiment;Electrocardiography;Chest X-ray;Concomitant medications survey;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSeunghoon Lee
Kyung Hee University Oriental Medical Center
Outcome results
None listed