Clinical trial NCT04462666: Oral Huzhang Granules for Acute Gouty Arthritis
Official title: Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gouty Arthritis
Keywords: Gouty arthritis
Randomized controlled trial
Huzhang granule
Traditional Chinese medicine
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute gout arthritis as defined by the American College of Rheumatology 1977 preliminary criteria;
* Male or non-pregnant, non-nursing female;
* 18-70 years of age;
* Gout attack less ≤48 hours;
* In the week before this observation, non-steroidal anti-inflammatory drugs and analgesic drugs and drugs affecting uric acid metabolism were not taken;
* Subjects capable of giving informed consent;

Exclusion Criteria:

* failing to meet the diagnostic criteria;
* Evidence of uncontrolled concomitant cardiovascular, nervous system,hepatic or gastrointestinal disease. Potential participants who have active concomitant disease can only be eligible after discussion and agreement with the treating medical team;
* the patient is in critical condition and it is difficult to evaluate the effectiveness and safety of the clinical observation;
* severe deformity, stiffness and labor loss of patients with advanced arthritis;
* known allergic to the drug used in this study.

Primary outcomes:
measure: Visual Analogue Score (VAS)
timeFrame: Up to 5 days after treatment
Secondary outcomes:
measure: Likert scales for the assessment of joint tenderness and swelling
timeFrame: Up to 5 days after treatment
measure: symptom relief time
timeFrame: Up to 5 days after treatment
measure: 36-Item Short Form Survey
timeFrame: Up to 5 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Yueyang Integrated Medicine Hospital, Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References:
citation: Zhou M, Hua L, Wang YF, Chen ST, Yang CM, Zhang M, Li X, Li B. Oral Huzhang granules for the treatment of acute gouty arthritis: protocol for a double-blind, randomized, controlled trial. Trials. 2022 Apr 1;23(1):248. doi: 10.1186/s13063-022-06188-x.