Condition category
Musculoskeletal Diseases
Date applied
05/07/2013
Date assigned
08/08/2013
Last edited
08/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chuanhu anti-gout mixture has been used for many years for treating gout in Chinese Traditional Medicine (TCM), while current standards for treatments for acute gouty arthritis (such as anti-inflammatory drugs [NSAIDs], colchicine and corticosteroids) were either less effective or had serious side-effects. The present study was designed to test the effectiveness of Chuanhu anti-gout mixture for therapy of acute gouty arthritis compared to colchicines.

Who can participate?
Adults with a new clinical diagnosis of gout and onset of the disease duration less than 48 hours were eligible to participate.

What does the study involve?
The participants were randomly allocated to one of the two groups:
Chuanhu group: to receive Chuanhu anti-gout mixture orally daily and placebo (dummy).
Colchicine group: to receive Colchicine 1 piece orally two times daily, for 3 days, later change to once daily, and placebo (dummy).
All of the patients were treated with etoricoxib 60 mg once daily orally to relieve pain of the affected joints for 10 days.

What are the possible benefits and risks of participating?
Chuanhu anti-gout mixture might be effective for therapy of acute gouty arthritis, and have fewer side-effects compared to colchicine. The possible risks include the adverse reactions pain, swelling and activity limitation of the joint, together with injury/damage to the liver and kidney.

Where is the study run from?
The study was run in the Affiliated Hospital of Qingdao University Medical College, Qingdao, China.

When is the study starting and how long is it expected to run for?
The study started in November 2011 and ran until November 2012.

Who is funding the study?
The study was founded by the Affiliated Hospital of Qingdao University Medical College and National Natural Sciences Foundation of China.

Who is the main contact?
Prof. Yangang Wang
wangyg1966@126.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Youxin Wang

ORCID ID

Contact details

10 Youanmenwai Xitoutiao
Beijing
100069
China
+86 10 83911497
wangy@ccmu.edu.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chuanhu anti-gout mixture versus Colchicine for acute gouty arthritis: a randomized, double-blind, double-dummy, non-inferiority trial

Acronym

Study hypothesis

Chuanhu anti-gout mixture has been used for many years in Chinese Traditional Medicine (TCM), and may be an effective treatment for acute gouty arthritis.

Ethics approval

The study was approved by Qingdao University’s ethics committee, Nov 1st, 2010

Study design

Randomized double-blind double-dummy non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet
Dr.Yunlong Wang, Tel: 0086-13581562524, Email: wylsun@163.com

Condition

Acute gouty arthritis

Intervention

Following screening, eligible patients were randomized (1:1) to two groups:
1. Chuanhu group, to receive Chuanhu anti-gout mixture 250ml orally daily and placebo (looks like colchicine).
2. Colchicine group, to receive Colchicine 1 piece orally (0.5mg per piece), 2 times daily, for 3 days, later change to once daily, and placebo (looks like Chuanhu anti-gout mixture).
All of the patients were treated with etoricoxib 60mg once daily orally to relieve pain of the affected joints for 10 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Chuanhu, Colchicine

Primary outcome measures

The recurrence rate within three months of these selected patients after 10 days’ treatment

Secondary outcome measures

1. The changes of white blood cells and C-reactive protein (CRP).
White blood cells were measured at North West University Nutrition laboratory using an AcT 5diff Cap Pierce Hematology Analyzer, and CRP was measured by immunoturbidimetric test, at the baseline and after 10days of follow up.
2. Adverse reactions, the score of pain, swelling, and activity limitation of the joint (1-4 point scale, for absent, mild, moderate, or severe, respectively), were recorded in the patient diary, and biochemical indicators were detected.

Overall trial start date

01/11/2011

Overall trial end date

01/11/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Adults >=18 year old, either sex, with a new clinical diagnosis of gout according to the 1977 American College of Rheumatology classification criteria and onset of the disease duration less than 48 hours were eligible to participate.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

176

Participant exclusion criteria

1. Secondary gout, such as rheumatoid arthritis, septic arthritis, traumatic arthritis, etc
2. Gout in intermittent period or with tophi
3. Taking the following drugs: diuretics, pyrazinamide, aspirin, etc
4. Pregnancy, breast-feeding women
5. Cardiovascular and cerebral vascular disease, and severe trauma or underwent surgery
6. Severe infections
7. Hepatobiliary disease or whose ALT and AST were two times higher than upper limit of normal
8. The serum creatinine greater than the upper limit of normal
9. Severe chronic gastrointestinal disease
10. Hematological diseases or endocrine system diseases
11. Undergoing cancer treatment
12. Receiving steroid therapy
13. Allergic to those known ingredients in Chuanhu anti-gout mixture.

Recruitment start date

01/11/2011

Recruitment end date

01/11/2012

Locations

Countries of recruitment

China

Trial participating centre

10 Youanmenwai Xitoutiao
Beijing
100069
China

Sponsor information

Organisation

The Affiliated Hospital of Medical College Qingdao University (China)

Sponsor details

c/o Prof.Yangang Wang
Department of Endocrinology
16 Jiangsu Road
Qingdao
266003
China
+86 532 82911399
wylapollo@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Affiliated Hospital of Qingdao University Medical College (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The study was in part supported by National Natural Science Foundation of China (81001281)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes