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

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

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Gout

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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HuZhen Capsule

The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.

Group Type EXPERIMENTAL

HuZhen Capsule

Intervention Type DRUG

Patients should take 4 tablet once and 3 times per day for 3 days.

Placebo Capsule

Placebo appearance, content color and taste should be consistent with HuZhen Capsule.

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type DRUG

Patients should take 4 tablet once and 3 times per day for 3 days.

Interventions

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HuZhen Capsule

Patients should take 4 tablet once and 3 times per day for 3 days.

Intervention Type DRUG

Placebo Capsule

Patients should take 4 tablet once and 3 times per day for 3 days.

Intervention Type DRUG

Other Intervention Names

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capsule A capsule B

Eligibility Criteria

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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 ℃)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No