Clinical trial NCT02674776: Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout
Official title: A Clinical Trial About the Efficacy and Safety of HuZhen Capsule in Treating Patients With Acute Gout: A 72 Hours, Multi-center, Randomized, Double-blind, Parallel Placebo Compared Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Gout
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 ℃)

Primary outcomes:
measure: Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
timeFrame: baseline,72 hours
Secondary outcomes:
measure: Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention
timeFrame: 72 hours
measure: Change in C-reactive protein (CRP) from baseline to 72 hours
timeFrame: baseline,72 hours
measure: Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
timeFrame: baseline,72 hours
measure: Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
timeFrame: baseline,72 hours
measure: The number of adverse events related to treatment
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bei Jing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jiang Quan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: