Efficacy, Safety and Economic Evaluation of Gamidaeganghwal-tang for Degenerative Knee Osteoarthritis : A multicenter, randomized, double-blind, parallel clinical trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 240

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

1. Patients with a history of knee joint trauma within 6 months of screening
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 the following treatment:
- intra-articular injection treatments such as intra-articualr corticosteroid within 6 months of screening
- injections such as hyalurnoic acid injcetion within 6 months of screening
4. Patients who are suspected to have following diseases in physical examination and diagnostic examination
: rheumatoid arthritis, autoimmune disease, septic arthritis, inflammatory joint disease, gout, recurrent pseudogout, Paget's disease, joint fractures, histioplegia, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrosis, genetic disorders (e.g. hyperkinesia), collagen gene abnormality etc.
5. Patients with musculoskeletal disorders that may affect this study as judged by the researcher (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 (serum creatinine > 2.0 ?/?)
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 a history of hypersensitivity or allergy to the components of investigational product.
11. Patients with galactose intolerance or lactase deficiency
12. Patients with a history of hypersensitivity to piroxicam, aspirin asthma or patients who develop urticaria, rhinitis or angioedema to aspirin or other non-steroidal anti-inflammatory drugs.
13. Patients who are taking herbal medicines or health functional foods that overlaps with investigational products.
14. Pregnant or lactating women
15. Patients whom the researcher judged not suitable for herbal medicine treatment
16. Patients who have participated in another clinical trial within either 4 weeks of the start of the clinical trial or 5 times of the half-life of an investigational product or are currently participating in another clinical trial
17. Patients with difficulty in stopping taking anti-inflammatory drugs
18. Participants deemed by the researchers to be unqualified to participate in the clinical trial.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Korean version of Western Ontario and McMaster Scale (KWOMAC)

Secondary Outcome Measures

Name	Time	Method
100 mm pain visual analog scale (VAS);European Quality of Life Five-Dimension-Five-Level Scale (EQ-5D-5L);Variation of KWOMAC by subgroup according to cold-heat pattern identification;Variation of 100mm Pain VAS by subgroup according to cold-heat pattern identification;Treatment satisfaction evaluation;Economic evaluation;Rescue medication;Number of days of contraindicated drug use or treatment;Proportion of subjects who received rescue drugs by group;Proportion of subjects who used contraindicated drug or received contraindicated treatment by group