Acute Gout
Conditions
Brief summary
This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.
Detailed description
The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.
Interventions
DRUGHuZhen Capsule
Patients should take 4 tablet once and 3 times per day for 3 days.
DRUGPlacebo Capsule
Patients should take 4 tablet once and 3 times per day for 3 days.
Sponsors
Quan Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Score is equal to or larger than 40cm on the 0-100cm VAS pain scale. 2. Acute attack of gout no longer than 2 days. 3. Participant with acute gout is diagnosed as damp-heat retention by Traditional Chinese medicine. 4. Age 18-65 years with informed consent.
Exclusion criteria
1. Chronic gouty arthritis. 2. Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis. 3. Anti-inflammatory medication for the treatment of acute gout. 4. Pregnant or breastfeeding women. 5. History of severe allergy, including diclofenac sodium. 6. Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times. 7. Fever ( T\>38.5 ℃)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of VAS (visual analog scale) score from baseline to 72 Hours after onset | baseline,72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention | 72 hours | Refer to theGuidline for Clinical Study of New Chinese Medicines |
| Change in C-reactive protein (CRP) from baseline to 72 hours | baseline,72 hours | Units of Measure:mg/L |
| Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours | baseline,72 hours | Units of Measure:mm/hour |
| Change in white blood cell count in whole blood cell analysis from baseline to 72 hours | baseline,72 hours | — |
| The number of adverse events related to treatment | 72 hours | — |
Countries
China
Outcome results
None listed