Chuanhu anti-gout mixture in therapy of acute gouty arthritis
| ISRCTN | ISRCTN65219941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65219941 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/07/2013
- Registration date
- 08/08/2013
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
10 Youanmenwai Xitoutiao
Beijing
100069
China
| Phone | +86 10 83911497 |
|---|---|
| wangy@ccmu.edu.cn |
Study information
| Study design | Randomized double-blind double-dummy non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheetDr.Yunlong Wang, Tel: 0086-13581562524, Email: wylsun@163.com |
| Scientific title | Chuanhu anti-gout mixture versus Colchicine for acute gouty arthritis: a randomized, double-blind, double-dummy, non-inferiority trial |
| Study objectives | 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(s) | The study was approved by Qingdao Universitys ethics committee, Nov 1st, 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Chuanhu, Colchicine |
| Primary outcome measure | 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 study start date | 01/11/2011 |
| Completion date | 01/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 176 |
| Total final enrolment | 176 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 01/11/2012 |
Locations
Countries of recruitment
- China
Study participating centre
100069
China
Sponsor information
Hospital/treatment centre
c/o Prof.Yangang Wang
Department of Endocrinology
16 Jiangsu Road
Qingdao
266003
China
| Phone | +86 532 82911399 |
|---|---|
| wylapollo@163.com | |
"ROR" |
https://ror.org/026e9yy16 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/06/2014 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference and total final enrolment added.
