None listed
Conditions
Interventions
Drug : Test group will be instructed to take orally Dokhwalgisaeng-tang 5g of 1 pack per dose three times a day 30 minutes after meals. The daily dose is 15g and the total duration of treatment is 12
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged from 40 to 70 2. Patients suffering knee pain from knee osteoarthritis for more than 3 months. 3. Patients diagnosed with knee osteoarthritis according to ACR criteria and at the same time, whose target lesion is Kellgren-Lawrence grade ?~? in simple X-ray. 4. Patients with a total score of 30 or higher on KOWAC which is done at the screening visit. 5. Patients who can agree to discontinue any existing treatment and can cooperate. 6. Patients voluntarily agreed to participate in the study 7. Patients with unilateral osteoarthritis or bilateral osteoarthritis whose target lesion can be designated to one side according to the following standard: If both knees meet the selection/exclusion criteria, target lesions are designated according to the criteria below. ? Designate the one with the higher Kellgren-Lawrence grade as the target lesion. ? If the Kellgren-Lawrence grade is the same, the one with the higher pain felt by the subject during the screening interview is designated as the target lesion. ? If all criteria of ?~? are the same, designate the right knee as the target lesion.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of knee joint trauma within the last 6 months. 2. Patients with a history of knee joint surgery or a plan for surgery during the clinical study period 3. Patients with a history of any intra-articular injection treatment within the last 3 months 4. Patients who are suspected of the following disease through physical or diagnostic medical examination: Rheumatoid arthritis, autoimmune disease, septic arthritis, inflammatory joint disease, gout, recurrent pseudogout, Paget's disease, joint fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrosis, genetic diseases (e.g. hyperkinesia), collagen gene abnormalities, etc. 5. Patients with musculoskeletal disorders which the researcher judged would affect this study. (e.g. hip or spine problems) 6. Patients receiving treatment for mental disorders such as depression and schizophrenia 7. Patients with liver disease (AST or ALT > 2 times the normal range) 8. Patients with renal disease (creatinine clearance < 30mL/min) 9. Patients with other diseases that may interfere with treatment, such as serious gastrointestinal or cardiovascular diseases, uncontrolled hypertension or diabetes, serious kidney or liver diseases, or hemorrhagic diseases 10. Patients with concomitant diseases or hypersensitivity reactions for whom the prescription of non-steroidal anti-inflammatory drugs is contraindicated. 11. Pregnant or lactating women 12. Patients whom the researcher judged not suitable for herbal medicine treatment 13. Patients who have participated in another clinical trial within 4 weeks of the start of the clinical trial or are currently participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KWOMAC | — |
Secondary
| Measure | Time frame |
|---|---|
| 100 mm pain VAS;EQ-5D-5L;Economic evaluation;Treatment satisfaction evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactYeoncheol Park
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed