Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout

Acute Gout Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02674776
• Other study ID #: 2013003P3A03
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 28, 2016
• Last updated: June 17, 2016
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ?)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gout
• Gout

Intervention

Drug:
• HuZhen Capsule
Patients should take 4 tablet once and 3 times per day for 3 days.
• Placebo Capsule
Patients should take 4 tablet once and 3 times per day for 3 days.

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Bei Jing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Quan Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of VAS (visual analog scale) score from baseline to 72 Hours after onset		baseline,72 hours	No
Secondary	Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention	Refer to the"Guidline for Clinical Study of New Chinese Medicines "	72 hours	No
Secondary	Change in C-reactive protein (CRP) from baseline to 72 hours	Units of Measure:mg/L	baseline,72 hours	No
Secondary	Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours	Units of Measure:mm/hour	baseline,72 hours	No
Secondary	Change in white blood cell count in whole blood cell analysis from baseline to 72 hours		baseline,72 hours	No
Secondary	The number of adverse events related to treatment		72 hours	Yes