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Clinical research protocol on the treatment of acute gout (phlegm-stasis-paralysis type) with Kunduan Yimu Decoction

Clinical research protocol on the treatment of acute gout (phlegm-stasis-paralysis type) with Kunduan Yimu Decoction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000542
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute gouty arthritis

Interventions

control group:Kunduan Yimu decoction simulant : the main component is starch
Test team:Kunduan Yimu Decoction

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Those who meet all the following conditions can be included : ( 1 ) Meeting the diagnostic criteria for acute gouty arthritis ( 2015 American College of Rheumatology ( ACR ) / European League Against Rheumatism ( EULAR ) gout classification criteria ) ; ( 2 ) TCM syndrome differentiation is phlegm and blood stasis type ; ( 3 ) The remission time of previous acute gouty arthritis was = 14 days ; ( 4 ) The time from the onset of the disease is not more than 48 hours ; ( 5 ) The pain VAS score of the target joint ( the most severely affected joint ) was = 40mm ; ( 6 ) Aged 18 to 65 years old ( including both ends ) regardless of gender ; ( 7 ) Those who volunteered to participate in this study and signed written informed consent.

Exclusion criteria

Exclusion criteria: One of the following will be excluded : ( 1 ) Secondary gout or joint lesions caused by other diseases ; joint lesions caused by chemotherapy radiotherapy chronic lead poisoning acute obstructive nephropathy etc. ; ( 2 ) Chronic gout attack intermittent period chronic gouty arthritis ; ( 3 ) The attack of acute gouty arthritis was more than 4 joints involved ; ( 4 ) Combined with late deformity disability loss of labor due to pain induced cardiovascular and cerebrovascular diseases ; combined with bronchitis pneumonia and other lower respiratory tract infections ; ( 5 ) Taking drugs that affect blood uric acid metabolism such as hydrochlorothiazide furosemide diuretic acid pyrazinamide high-dose aspirin and drugs containing the above components such as compound antihypertensive tablets ; or taking glucocorticoids within 1 month before enrollment ; or use non-steroidal anti-inflammatory drugs or other analgesics within 24 hours before baseline evaluation ; ( 6 ) Patients who had used acute gouty arthritis treatment drugs ( such as colchicine non-steroidal anti-inflammatory drugs glucocorticoids and topical ointments and dressings for the treatment of acute gouty arthritis ) ; ( 7 ) Patients with anemia hemorrhoids peptic ulcer Crohn 's disease acute infectious diseases autoimmune diseases ; ( 8 ) Women of childbearing age who are pregnant or preparing for pregnancy lactating women or who are unable or unwilling to take adequate contraception during the trial period ( 9 ) Psychiatric patients or patients who cannot cooperate with treatment ; ( 10 ) Renal function Scr more than 1.2 times the upper limit of the reference value ; liver function ALT AST more than 1.5 times the upper limit of the reference value ; ( 11 ) Patients with severe cardiovascular cerebrovascular liver kidney hematopoietic and endocrine systems and other serious primary diseases ; ( 12 ) Allergic constitution or allergic to Kunduan Yimu Decoction acetaminophen tablets and their corresponding excipients in this study ; ( 13 ) Suspected or had a history of alcohol and drug abuse ; ( 14 ) Patients who had participated in other clinical trials within 3 months ; ( 15 ) Other situations that the researchers believe are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Joint pain VAS score;

Secondary

MeasureTime frame
electrolytes;BUA;Use of emergency medication (acetaminophen tablets) during the trial period;Urine routine + sediment microscopy;ESR;Number of painful or swollen joints;Chinese Medicine Score;CRP;

Countries

China

Contacts

Public ContactQiang Xu

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

xuqiang@gzucm.edu.cn13430372875

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026