Efficacy and safety of GyejigaChulBuTang(GCB) for knee pain in patients with Degenerative Knee Osteoarthritis : A multicenter, randomized, controlled, patient-assessor blind, clinical trial
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003024
- Lead Sponsor
- Dunsan Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
1. Patients over 40 years old
2. A person who complains of more than VAS 30 mm of pain in his knee during his or her daily life.
3. Over grade 2 on Kellgren-Lawrence Grading Scale
4. A person who voluntarily decides to participate and agrees to the written agreement after having received a full explanation of the research objectives and processes
1. Person with severe knee trauma in the last 6 months
2. Person with medical history of knee or planning for surgery within the research period
3. Person who received injection treatment such as steroids within 3 months and hyaluronic acid within 6 months
4. Person with a history of acupuncture, herbal acupuncture and herbal medicine for knee pain relief within the last month
5. Screening Clinical Examination ESR > 40 mmh, 1. RA Factor>20U/mL
6. Persons with musculoskeletal problems that cause more pain than knee pain in other body parts
7. If you have an uncontrolled heart condition such as angina, congestive heart failure, or if your blood test results in liver(AST, ALT levels are 40 Ul or higher), and the kidney function is abnormal(Creatine 0.5-0.9mg/dl, BUN 6-20mg/dl), systolic blood pressure is at least 180m mmg or greater than 100m mm even after two or three repeated measurements
8. People who are pregnant, nursing or diagnosed with malignant tumors
9. Galactose intolerance, lappase lactase deficiency, or glucose deficiency
10. A neuropsychiatrics who has significant history or is currently ill
11. Other members of the clinical research team think they are unsuitable
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS
- Secondary Outcome Measures
Name Time Method K-WOMAC;PGIC(Patient Global Impression of change);Adverse event