NCT04462666

Oral Huzhang Granules for Acute Gouty Arthritis

Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

We designed this study as a double-blind, randomized, controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of acute gouty arthritis

Detailed description

Gout is a recurrent chronic inflammatory disease caused by monosodium urate (MSU) crystal . Acute gouty arthritis (GA) is the most common first symptom of gout. With the progress of the disease, the frequency of acute attack increases, and joint destruction may occur. The prevalence of hyperuricemia in China was about 13.3%, and the pooled prevalence of gout was 1.1%. Repeated attacks of GA seriously affect the quality of life, resulting in huge economic costs and mental stress. Due to inadequate prevention and treatment, the target of healing gout is often not achieved. In GA, TCM has shown satisfactory therapeutic effect with less adverse effects and minimal toxicity. Huzhang granule (HZG), a Chinese herbal prescription, is a compound preparation with twelve ingredients which has been used in the clinical treatment of gout for over 30 years at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of TCM.Therefore，this double-blind, randomized, controlled clinical trial. will provide high-quality clinical evidences for evaluating the clinical efficacy, safety and control of recurrence rate of Huzhang granule ，a representative prescription for the treatment of acute gouty arthritis , in the treatment of GA.

Conditions

• Gouty Arthritis

Interventions

Type	Name	Description
DRUG	Huzhang granule	Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
DRUG	Etoricoxib	take one capsule per day in the morning, at approximately 30 minutes after the meal.
DRUG	Huzhang granule Placebo	Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
DRUG	Etoricoxib Placebo	take one capsule per day in the morning, at approximately 30 minutes after the meal.

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-07-31
• Completion: 2023-08-31
• First posted: 2020-07-08
• Last updated: 2020-07-08