Oral Huzhang Granules for Acute Gouty Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-08-31

Brief Summary

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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

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Detailed Description

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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

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Gouty Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HZG intervention

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.

Group Type EXPERIMENTAL

Huzhang granule

Intervention Type DRUG

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.

Etoricoxib Placebo

Intervention Type DRUG

take one capsule per day in the morning, at approximately 30 minutes after the meal.

Etoricoxib intervention

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.

Group Type ACTIVE_COMPARATOR

Etoricoxib

Intervention Type DRUG

take one capsule per day in the morning, at approximately 30 minutes after the meal.

Huzhang granule Placebo

Intervention Type DRUG

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.

Placebo intervention

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.

Group Type PLACEBO_COMPARATOR

Huzhang granule Placebo

Intervention Type DRUG

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.

Etoricoxib Placebo

Intervention Type DRUG

take one capsule per day in the morning, at approximately 30 minutes after the meal.

Interventions

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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.

Intervention Type DRUG

Etoricoxib

take one capsule per day in the morning, at approximately 30 minutes after the meal.

Intervention Type 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.

Intervention Type DRUG

Etoricoxib Placebo

take one capsule per day in the morning, at approximately 30 minutes after the meal.

Intervention Type DRUG

Other Intervention Names

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Chinese Herbal Medicine Chemical drug Chinese Herbal Medicine Chemical drug

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No