Overview

This trial is active, not recruiting.

Condition acute gout
Treatments huzhen capsule, placebo capsule
Phase phase 3
Sponsor Quan Jiang
Start date September 2015
End date December 2016
Trial size 480 participants
Trial identifier NCT02674776, 2013003P3A03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.
huzhen capsule capsule A
Patients should take 4 tablet once and 3 times per day for 3 days.
(Placebo Comparator)
Placebo appearance, content color and taste should be consistent with HuZhen Capsule.
placebo capsule capsule B
Patients should take 4 tablet once and 3 times per day for 3 days.

Primary Outcomes

Measure
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
time frame: 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
time frame: 72 hours
Change in C-reactive protein (CRP) from baseline to 72 hours
time frame: baseline,72 hours
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
time frame: baseline,72 hours
Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
time frame: baseline,72 hours
The number of adverse events related to treatment
time frame: 72 hours

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 ℃)

Additional Information

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
Principal investigator Jiang Quan, Doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.