The study of clinical efficacy and safety of traditional medicine, Gumiganghwal-tang in knee osteoarthritis

Not Applicable

Completed

Conditions: Diseases of the musculo-skeletal system and connective tissue

Registration Number: KCT0002368

Lead Sponsor: Soon Chun Hyang University Hospital Cheonan

Brief Summary: A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, 71.3 ± 1.6 (treatment and placebo group, respectively, p=0.84) and total WOMAC score was 55.2 ± 1.6, 55.6 ± 1.5 (p = 0.84). After 6-weeks, the pain VAS was 43.0 ± 2.5, 61.6 ± 2.5 (treatment and placebo group, respectively, p < 0.01) and the total WOMAC score was 34.1 ± 2.4, 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 161

Inclusion Criteria

Participants who met the following inclusion criteria were recruited to the trial: age 40 years or older, diagnosis of clinical symptomatic knee osteoarthritis defined using the American College of Rheumatology (ACR) criteria for at least 3 months before screening, documented radiographic changes indicating osteoarthritis of the knee (Kellgren-Lawrence grade greater than or equal to 2 at the time of screening), pain in at least one knee with a visual analogue scale pain score of = 50 mm and < 80 mm ( 1-100 mm scale), pain requiring analgesia or nonsteroidal anti-inflammatory drugs (NSAIDs) /selective COX-2 inhibitors at least 5 days or more a week in the last month, not pregnant or lactating, use of effective contraception if participant is a woman of childbearing age, and a signed consent statement.

Exclusion Criteria

Patients with congestive heart failure, uncontrolled hypertension, a history of stroke, renal artery stenosis, ischemic heart disease or renal failure, hypersensitivity or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs)/aspirin/selective cox-2 inhibitor, hemostatic dysfunction including concurrent warfarin treatment, inability to provide informed consent, who were pregnant or lactating were excluded. Patients were also excluded if they had concurrent disease resulting in secondary osteoarthritis such as a fracture, septic arthritis or inflammatory arthritis, if they underwent orthopedic surgery within the 6 months prior to screening, or if they planned to have a surgical procedure during the study period.