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

NCT02674776 | Unknown Phase 3 DMC

• 1 other identifier: 2013003P3A03
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Gout

Outcome Measures

Primary Outcomes (1)

• Change of VAS (visual analog scale) score from baseline to 72 Hours after onset

  baseline,72 hours

Secondary Outcomes (5)

• Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention

  72 hours

• Change in C-reactive protein (CRP) from baseline to 72 hours

  baseline,72 hours

• Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours

  baseline,72 hours

• Change in white blood cell count in whole blood cell analysis from baseline to 72 hours

  baseline,72 hours

• The number of adverse events related to treatment

  72 hours

Study Arms (2)

HuZhen Capsule

EXPERIMENTAL

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

Drug: HuZhen Capsule

Placebo Capsule

PLACEBO COMPARATOR

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

Drug: Placebo Capsule

Interventions

HuZhen Capsule DRUG

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

Also known as: capsule A

HuZhen Capsule

Placebo Capsule DRUG

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

Also known as: capsule B

Placebo Capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
• Acute attack of gout no longer than 2 days.
• Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
• Age 18-65 years with informed consent.

You may not qualify if:

• Chronic gouty arthritis.
• Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
• Anti-inflammatory medication for the treatment of acute gout.
• Pregnant or breastfeeding women.
• History of severe allergy, including diclofenac sodium.
• Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
• Fever ( T\>38.5 ℃)

Sponsors & Collaborators

• Quan Jiang: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100052, China

Location

Study Officials

• Jiang Quan, Doctor

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Professor of Rheumatology Devision

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 4, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

CN (1)