Hyperuricemia
Conditions
Interventions
Control group:Basic diet exercise guidance+Febuxostat Tablets +Modified ShuiluErxian Decoction simulant
experiment:Basic diet exercise guidance + febuxostat tablet simulant + Modified ShuiluErxian Decoction
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) According to the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019 Edition) those who meet the western medical diagnosis of hyperuricemia: 1) Under the normal purine diet the serum uric acid level measured by both men and women under the condition of twice fasting on the same day is higher than 420µmol/L and those who have been diagnosed with hyperuricemia in the past have reached the initial treatment standard of reducing uric acid; (2) Meet the initial criteria of drug therapy for reducing uric acid: blood uric acid level =540µmol/L or blood uric acid level =480µmol/L with one of the following complications: hypertension abnormal lipid metabolism diabetes obesity stroke coronary heart disease cardiac insufficiency uric acid nephrolithiasis and renal dysfunction (=CKD2 stage). (2) According to the Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine (Trial) and the National Standard for Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine: Syndromes and combined with the actual clinical situation the diagnostic criteria of hyperuricemia in this study are formulated: Main symptoms: obesity limb fatigue lack of breath and laziness weak waist and knees; Secondary symptoms: abdominal distension anorexia loose stool dizziness and tinnitus adverse urination frequent urination at night; Tongue pulse: the tongue is light fat or dark the coating is white and greasy and the pulse is slow or heavy. Have at least two symptoms in the main symptoms one in the secondary symptoms or one in the tongue pulse; (3)18 years old =65 years old; (4) Patients voluntarily participate in and sign the informed consent form; (5) Women of childbearing age are required to have a negative pregnancy test when entering the group and agree to use reliable contraceptive measures during the study.
Exclusion criteria
Exclusion criteria: (1) Patients with acute gouty arthritis tophi diagnosis and secondary hyperuricemia caused by other diseases; (2) Liver function damage (ALT/AST is 1.5 times higher than the upper limit of normal) and renal function damage (Cr is higher than the upper limit of normal or EGFR is less than 60 umol/L) during screening; (3) Suffering from malignant tumor hematological diseases or serious psychosomatic diseases or suffering from serious diseases with a life expectancy of less than 2 years; (4) Those who are known to be allergic to the ingredients in Jiawei Shuilu Erxian Decoction group or its preparation and who are not allergic to Bustatista; (5) Participants in other clinical trials in recent 3 months; (6) Patients who received immunosuppressive therapy or glucocorticoid therapy in the first half of the study or expected to receive it and patients who used or could not stop using drugs affecting uric acid metabolism within two weeks before the study (such as azathioprine 6- mercaptopurine aspirin (=325 mg) or other drugs such as salicylic acid and thiazide diuretics); (7) women of childbearing age who are pregnant pregnant breastfeeding and unwilling to use effective contraceptive methods; (8) The researcher judges that the patient's compliance is poor and it is not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood uric acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| biochemical index;Stool testing;Chinese Medicine Score;vital signs;urine test;terminal event; | — |
Countries
China
Contacts
Public ContactGaohong
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed