None listed
Conditions
Interventions
Dietary Supplement : Experimental Group: Perilla Frutescens extract (PFE) capsules (700 mg/capsule containing 486 mg of PFE plus 214 mg of excipient)
Control Group: Placebo capsules (700 mg/capsule,
soybean oil 83%, palm oil 11.25%, beeswax 3.75%, and soybean lecithin 2.00%)
Each participant will orally administrate either PFE capsules or placebo capsules after meals with sufficient water, twice
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female adults aged 20-75 years at the time of the screening test. 2) Adults complain of mild knee pain, as VAS score same or less than 50mm (without recent any type of joint injury or similar episode; 0 and 100 indicate ‘no pain’ and ‘unbearable pain’, respectively). 3) People who voluntarily participate in the trial with written consent.
Exclusion criteria
Exclusion criteria: 1) A person who is currently taking arthritis-related medications. 2) A person is accompanied by osteoporosis around the joint, irregular joint surface, and subchondral osteocytes of the joint and is moderate to severe arthritis as identified on plain radiographs (moderate to severe arthritis as identified on plain radiographs: Kellgren-Lawrence (K-L) grade = 3 on plain radiographs). 3) A person who has a medical history of knee arthroplasty surgery. 4) A person who has been diagnosed with other musculoskeletal disorders other than knee joint pain and is being treated for pain. 5) A person who is taking products containing PFE or has a history of a significant overreaction (including allergic reaction). 6) A woman who is pregnant or breastfeeding 7) A person who has an important heart, kidney, liver, and other organ disease or is expected to affect the evaluation of abnormal reactions after participating in the human application test or interfere with the completion of the human application test. 8) A person who is treating gastritis and stomach ulcers. 9) A person with a history of significant medical treatment/surgery that may affect the human application test. 10) A person with a history of gastrointestinal disorders (e.g., Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of human-applied test products. 11) A person who has consumed drugs, herbal medicines, and healthy functional foods that may affect joint health within 2 weeks (glucosamine, NAG, mucopolysaccharide - protein, MSM, green leaf mussel oil, Scutellaria baicalensis, rose hip powder, fatty acid compound (FAC), Boswellia extract, ginseng extract, Achyranthes japonica Nakai, etc.). 12) A person with mental illness such as schizophrenia, drug addiction, etc., and being treated for depression. 13) A person who has therapeutic history due to alcoholism or drug abuse. 14) A person who has participated in another human body application test within two months prior to screening. 15) A person who exhibits the following results in a laboratory inspection. ? AST, ALT> 3 times the upper limit of the reference range ? Serum Creatine> Twice the upper limit of the reference range 16) A person who has been determined unfit to participate in the study due to other reasons, including the results of the diagnostic examination medical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analouge scale(VAS);Western Ontario and McMaster Universities Arthritis Index (WOMAC) | — |
Secondary
| Measure | Time frame |
|---|---|
| cyclooxygenase-2 (COX-2), high sensitive C-reactive protein (HS-CRP), erythrocyte sedimentation rate (ESR), neutrophil and lymphocyte ratio, and cartilage oligomeric matrix protein (COMP).;Adverse events;Vital signs; laboratory examinations (hematological, hematochemical, urine tests) | — |
Countries
Korea, Republic of
Contacts
Public ContactEun-Jung Lee
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed