Oral Huzhang Granules for Acute Gouty Arthritis

Shanghai Yueyang Integrated Medicine Hospital

Status and phase: Unknown; Phase 2

Conditions: Gouty Arthritis

Treatments: Drug: Etoricoxib Placebo; Drug: Huzhang granule; Drug: Etoricoxib; Drug: Huzhang granule Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04462666

2020024

Details and patient eligibility

About

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

Full 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.

Enrollment: 267 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 3 patient groups, including a placebo group

HZG intervention

Experimental group

Description:

During the 5-day treatment period, participants in the Experimental group will receive 10 sacks of experimental granules. They will be instructed to take two sacks per day, one in the morning and one in the evening, in approximately 30 minutes after the meal.. The placebo etoricoxib will also be taken daily in the morning for 5 days.

Treatment:

Drug: Etoricoxib Placebo

Drug: Huzhang granule

Etoricoxib intervention

Active Comparator group

Description:

During the 5-day treatment period, participants in the Etoricoxib group will receive 5 Etoricoxib capsules. They will be instructed to take one capsule per day in the morning, at approximately 30 minutes after the meal. The placebo HZKL will also be taken daily in the morning for 5 days.

Treatment:

Drug: Huzhang granule Placebo

Drug: Etoricoxib

Placebo intervention

Placebo Comparator group

Description:

During the 5-day treatment period, participants in the Placebo group will receive 10 sacks of placebo HZG. They will be instructed to take two sacks per day, one sack in the morning and one in the evening, at approximately 30 minutes after the meal. And the placebo etoricoxib also be taken daily in the morning for 5 days.

Treatment:

Drug: Huzhang granule Placebo

Drug: Etoricoxib Placebo