None listed
Conditions
Interventions
Dietary Supplement :
- 450 mg/day of ethanol extract of Kaempferia parviflora (equivalent to 200 mg/day of ethanol-extracted Kaempferia parviflora powder)
- Orally administered with water after lunch
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged between 40 and 75 years 2. Individuals with a knee joint pain score of 3 or higher on the Visual Analogue Scale (VAS) 3. Individuals with grade 1 or 2 on the Kellgren & Lawrence grading scale based on anteroposterior (AP) and lateral (LAT) radiographs of both knee joints 4. Individuals who have completed a washout period of at least 4 weeks from medications or health supplements related to arthritis 5. Individuals with a body mass index (BMI) between 18 and 29 kg/m² 6. Individuals capable of normal physical activity who voluntarily agree to participate in the study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of bone fracture within the past year 2. Individuals with osteophyte formation around the joint, irregular joint surfaces, or subchondral bone cysts suggestive of moderate osteoarthritis 3. Individuals currently undergoing treatment for thyroid disorders 4. Individuals with kidney disease or serum creatinine levels = 1.4 mg/dL 5. Individuals with proteinuria of 2+ or higher 6. Individuals with liver disease (excluding fatty liver) or AST or ALT levels = 100 IU/L 7. Individuals with uncontrolled hypertension or a history of cardiovascular diseases such as angina or myocardial infarction 8. Individuals taking medication for psychiatric disorders (except those taking intermittent medication for sleep disorders) 9. Individuals who have taken any traditional herbal medicine or decoctions within 2 months prior to the screening visit 10. Individuals who have received investigational drugs within 4 weeks prior to the screening visit 11. Individuals who require continuous use of medications that may affect the outcome of the study 12. Individuals with a history of gastrointestinal surgery (excluding appendectomy) 13. Pregnant or breastfeeding women 14. Individuals with a history of alcohol abuse 15. Individuals with known hypersensitivity to the investigational product or its components 16. Individuals who are likely to be uncooperative or judged by the investigator to be unable to complete the study 17. Individuals diagnosed with arthritis caused by specific factors other than degenerative changes, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Total Score (Western Ontario and McMaster Universities Osteoarthritis Index) | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores for each subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), including pain, stiffness, and physical function.;VAS(Visual Analogue Scale);Inflammatory Markers (C-reactive protein (CRP) levels, Erythrocyte sedimentation rate (ESR)) | — |
Countries
Korea, Republic of
Contacts
Public ContactBong Jin Shin
Pusan National University Korean Medicine Hospital
Outcome results
None listed