None listed
Conditions
Interventions
Drug : A 43.9 g GMGHT granule and placebo was provided by Hanpoon Pharmaceuticals Inc. The placebo granule is indistinguishable to GMGHT in its taste, smell and color
its gradient is composed of excipients.
The subjects took the GMGHT or placebo twice a day
one capsule in the morning and one in the evening for 4-weeks
Sponsors
Soon Chun Hyang University Hospital Cheonan
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMasters Universities OA (WOMAC);adverse events associated with study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| patient's and physician's global assessment;study medication withdrowal due to adverse effect associated with study drugs | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong-Su Nah
Soon Chun Hyang University Hospital Cheonan
Outcome results
None listed