Clinical research on the efficacy and safety of Gyebutang Granule combined with acupuncture on knee osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003264
- Lead Sponsor
- Semyung University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Adults aged 40 to 69 years.
2. Those who follow the American College of Rheumatology (ACR) classification criteria for osteoarthritis of the knee and satisfy both ? and ? below.
? During the last 6 months, unilateral or bilateral knee arthritic pain has been reported during weight bearing activity.
? The knee arthritic pain is shown more than 40 ? on 100 ? Visual Analog Scale (VAS)
3. Those who decide to voluntarily participate in this clinical trial and agree in signing informed consent.
4. A person who is trusted and willing to cooperate with this trial for the next three months
1. A history of knee trauma within the last 6 months.
2. Operation history for the knee within the last 6 months.
3. Intra-articular injections (steroids, mucus supplements, etc.) within the last 3 months.
4. The physical and diagnostic examination indicate an inflammatory arthritis such as rheumatoid arthritis, infectious disease or autoimmune disease.
5. Those who are treated with mental disorders such as depression and schizophrenia.
6. Patients with liver disease (AST or ALT > normal range 2 times)
7. Patients with renal disease (serum creatinine > 2.0 ? / ?)
8. Those who have other diseases that may interfere with treatment, such as serious gastrointestinal diseases, cardiovascular diseases, hypertension, diabetes, kidney disease, liver disease, thyroid dysfunction etc.
9. Those who take restrictive disease, contraindication, hypersensitivity in using the prescription of non-steroidal anti-inflammatory drugs (NSAIDs).
10. Pregnant and lactating women.
11. If the researcher judge the subject is not suitable for enrolling trial.
12. Those who participated in other clinical trials within last 4 weeks or are currently participating in other clinical trials.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 100 mm Pain VAS (Vas Analogue Scale)
- Secondary Outcome Measures
Name Time Method K- WOMAC (Westren Ontario and McMaster Universities) Scale, subscale;Pain Numeral Rating Scale (NRS);EuroQoL-5D-5L;Patient global assessments (PGA);Adverse event