Phase IIA clinical trial of Bailing Tongfengxiao granules
- Conditions
- gout
- Registration Number
- ITMCTR2100004590
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Those who voluntarily participate in the test and sign the informed consent;
(2) Aged between 18 and 65 (including 18 and 65);
(3) Meet the Western diagnostic criteria for acute gouty arthritis (Gout Classification Standards, 2015, developed by the American College of Rheumatology (ACR) and the European League Against Rheumatology (EULAR));
(4) In line with the TCM syndrome differentiation criteria of dampness-heat stasis (refer to the Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes formulated by the State Administration of Traditional Chinese Medicine in 1994 and the Guiding Principles for Clinical Research of New Chinese Drugs formulated by the Ministry of Health of the People's Republic of China in 1995);
(5) The pain site of this acute attack is the lower limb joint;
(6) The acute onset is less than 48 hours;
(7) Pain VAS score >= 4;
(8) If you are on uric-lowering therapy, you must take the drug at a steady dose for 2 weeks prior to randomization and do not change your treatment regimen during the study period;
(9) Agree to use effective non-drug contraceptives during the trial.
(1) Intermittent gout or chronic tophi arthritis;
(2) advanced arthritis severe deformity, stiffness, loss of labor;
(3) complicated with other arthritis such as acute rheumatic fever, infectious arthritis, traumatic arthritis, pseudogout, rheumatoid arthropathy or spinal arthritis, or complicated with soft tissue swelling and pain of lower limbs such as erysipelas, phlebitis of lower extremities, diabetic foot, or complicated with other diseases that may affect the observation of curative effect;
(4) secondary gout;
(5) Patients with serious cardiovascular, cerebrovascular, liver, kidney and other serious diseases or psychosis;
(6) ALT, AST or TBIL are 1.5 ULN, or SCR is 1.2 ULN;
(7) Peripheral blood WBC < 3.5 x 10^9/L, or with definite anemia (HGB < 90g/L), or PLT < 80 x 10^9/L, or other blood system diseases;
(8) Use of drugs affecting efficacy observation during the first 2 weeks of randomization, including (meeting any of the following criteria):
1) Aspirin: not taking drugs regularly; Or regular daily dose of > 100mg;
2) Diuretics and other drugs that affect uric acid metabolism;
3) Colchicine, NSAIDs, glucocorticoids;
(9) After this acute attack, use acupuncture and moxibustion, pricking blood and other therapeutic therapies;
(10) Pregnant or lactating women;
(11) During the trial period and within 3 months after the last administration of the experimental drug, those who had a family planning plan;
(12) Allergic to this product or its ingredients;
(13) Suspecting or having a history of alcohol and drug abuse;
(14) Patients who participated in other clinical trials within the last 3 months;
(15) Investigator considers that other factors (such as conditions that may cause subjects to fail to complete the study or pose significant risks to subjects) are not appropriate for participants to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in VAS score from baseline for joint pain after treatment on day 5;
- Secondary Outcome Measures
Name Time Method Emergency drug use after the end of medication on day 5;Change in joint swelling score from baseline at the end of treatment on day 5;The change value of the curative effect of TCM syndrome differentiation after the end of medication on the 5th day compared with the baseline;Changes in the frequency of nocturnal pain awakening on days 2, 3, 4 and 5 from baseline;Disappearance rate of joint pain after treatment on day 2, 3, 4 and 5;Changes from baseline to the highest VAS score for joint pain on days 2, 3, 4, and 5;Changes in uric acid, erythrocyte sedimentation rate and C-reactive protein from baseline at the end of treatment on day 5;The VAS score for joint pain disappeared and decreased by 50%;