None listed
Conditions
Interventions
Drug : It is randomly assigned to either test group I, test group II, or placebo group, and take HPL-01 for 3 times a day 2 tablets for 12 weeks.
Sponsors
Hanpoong Pharm & Foods
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men or women age over 40 and under 50 2) Clinical diagnostic criteria for primary knee osteoarthritis of the American College of Rheumatology criteria 3 months prior to visit 1 3) Kellgren & Lawrence grading scale of the knee joint on X-ray is grade II, III 4) Daily average pain during the past week is 40mm ~ 74mm on the 100mm Pain Scale 5) Agreed to participate in this clinical trial and signed a Informed consent form before the clinical trial begins
Exclusion criteria
Exclusion criteria: 1) Those who have undergone surgery on the knee due to degenerative knee arthritis or other trauma 2) Those who have received an injection of intra-articular mucus supplements (viscosupplement; hylan, sodium hyaluronate, hyaluronan, etc.) within 9 months of visit 1 or who have discharged joint fluid through intraarticular injection 3) Those who have received prolotherapy or steroid injection treatment within the joint cavity and around the knee within 3 months of visit 1 4) Those who have received oriental medical treatments such as acupuncture, moxibustion, cupping, and herbal medicine for arthritis treatment within 4 weeks of visit 1 5) Those who have received non-pharmaceutical topical treatment such as physical therapy for arthritis treatment within 2 weeks of visit 1, or who have used topical analgesics (parse, spray, etc.) on the knee joint 6) Those who are taking osteoarthritis treatments (nonsteroidal anti-inflammatory drugs, COX-2 selective inhibitors, etc.) and joint/cartilage health improvement health functional foods including glucosamine within 2 weeks of visit 1 7) Those with a past or present history of inflammatory disease, tumor, rheumatoid arthritis, autoimmune disease, secondary arthritis, hip joint disease, or other inflammatory arthritis 8) Septic arthritis, gout, recurrent pseudogout, Paget's disease, joint fractures, tissue melanosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrosis, genetic disorders (e.g., hyperkinesia), with collagen gene abnormalities 9) Those who are taking corticosteroids, immunosuppressants, corticosteroids, cyclosporine, or other nonsteroidal anti-inflammatory drugs for other diseases 10) Those whose ALT(GPT) or AST(GOT) is more than 3 times the upper limit of normal range 11) Those whose Creatinine is more than twice the upper limit of normal range 12) Those who have a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of investigational drugs 13) Those with multiple sclerosis, connective tissue (collagen) disease 14) Those with skin allergies, skin ulcers, or skin infections 15) Those with mental disorders such as schizophrenia, drug addiction, and those being treated for depression 16) Those with a history of drug or alcohol abuse 17) Those with a history of allergy to the main ingredients of clinical investigational drugs 18) Pregnant or lactating women or women of childbearing potential who have not accepted the implementation of appropriate contraceptive methods (except for women who have undergone sterilization) 19) Those who judged that the investigator is inappropriate to participate in the clinical trial due to other reasons 20) Those who have participated in other clinical trials within 2 months of visit 1 or plan to participate in other clinical trials during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 100mm Pain VAS(Visual Analogue Scale) during activity | — |
Secondary
| Measure | Time frame |
|---|---|
| 100mm Pain VAS(Visual Analogue Scale) during activity;100mm Pain VAS(Visual Analogue Scale) during rest;WOMAC total scores;KSF-36 scores;ESR and CRP change amount;Remedy dosage;Patient‘s Global Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Chan Ha
Chung-Ang Univerisity Hospital
Outcome results
None listed