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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Gout
• Intervention / Treatment: Drug: HuZhen Capsule; Drug: Placebo Capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Bei Jing, Beijing, China, 100052
      • Guang'anmen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HuZhen Capsule; The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.	Drug: HuZhen Capsule; Patients should take 4 tablet once and 3 times per day for 3 days.; Other Names: capsule A
Placebo Comparator: Placebo Capsule; Placebo appearance, content color and taste should be consistent with HuZhen Capsule.	Drug: Placebo Capsule; Patients should take 4 tablet once and 3 times per day for 3 days.; Other Names: capsule B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset	baseline,72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in C-reactive protein (CRP) from baseline to 72 hours	Units of Measure:mg/L	baseline,72 hours
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours	Units of Measure:mm/hour	baseline,72 hours
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

Collaborators and Investigators

• Sponsor: Quan Jiang

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis, Gouty
• Other Study ID Numbers: 2013003P3A03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED