Effects of Anthriscus Sylvestris Leaves on Mild Knee Osteoarthritis
NCT Number: NCT06535204
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis|Articular Cartilage|Functional Food
Interventions: DIETARY_SUPPLEMENT: Aqueous extract of A. sylvestris leaves|DIETARY_SUPPLEMENT: microcrystalline cellulose
Sponsor: Pusan National University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2019-06-24
Completion Date: 2020-04-30
Locations: Pusan National University Hospital, Busan, Seo-gu, 49241, Korea, Republic of

Summary:
Osteoarthritis (OA) is a common degenerative joint disorder that causes pain, stiffness, and functional impairment. Current treatments for OA are limited to symptom relief and have potential side effects. Anthriscus sylvestris leaves are a natural remedy that has been shown to have anti-inflammatory and cartilage-protective effects in animal models of OA.

Primary Outcome Measures: WOMAC(Western Ontario and Mcmasters Universities), The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was assessed through a survey, with scores ranging from 0 to 96. Higher scores indicate worse outcomes., Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Secondary Outcome Measures: VAS(Visual Analogue Scale), The Visual Analogue Scale (VAS) was assessed through a survey, with scores ranging from 0 to 100. Higher scores indicate worse outcomes., Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)|Anti-inflammatory indicator, Concentration of C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR) were measured from blood samples collected from the Jeonju vein after fasting for 8 hours and analyzed in our hospital's laboratory., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)
Other Outcome Measures: Blood pressure, Blood pressure was measured in a sitting position after resting using BP-203 RVII(Colin Corp, Aichi, Japan)., Visit 1 (screening) Visit 2 (baseline) and Visit 3 (during the trial, 4week±7day) and Visit 4 (end of the trial) (12week±7day)|Body weight, Body weight in kilograms were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul)., Visit 1 (screening)|Height, Height in meters were measured using a digital scale and stadiometer (BSM370, Biospace Co Ltd, Seoul)., Visit 1 (screening)|Gathering subject information from the survey, All participants received information on demographics, history (diagnosis or drug treatment of hypertension, diabetes or dyslipidemia), health-related habits (smoking, drinking and alcohol), and medications taken through the survey. Participants were defined as non-smokers, past smokers, and current smokers, and non-smokers (0 to 98 g/week) or drinkers who drink an average of 7 cups of men and 5 or more cups of women twice per person., Visit 1 (screening)|Assessment of Bilateral Knee Joint Degeneration using AP/LAT Radiographs, Assessment of Bilateral Knee Joint Degeneration using AP/LAT Radiographs: Radiographic evaluation of bilateral knee joints will be performed using anterior-posterior (AP) and lateral (LAT) views. X-ray equipment in the hospital will be used to obtain these images. The degree of joint degeneration will be measured and reported based on established radiographic criteria, including the Kellgren-Lawrence grading scale., Visit 1 (screening)|Presence of Hepatitis B Surface Antigen (HbsAg), At Visit 1, the presence of Hepatitis B Surface Antigen (HbsAg) was tested through blood analysis., Visit 1 (screening)|Presence of Hepatitis C Virus Antibodies (Anti-HCV), At Visit 1, the presence of Hepatitis C Virus Antibodies (Anti-HCV) was tested through blood analysis., Visit 1 (screening)|Presence of Human Chorionic Gonadotropin (HCG) in Urine, At Visit 1, the presence of HCG in urine was tested for all females of reproductive age, excluding males and postmenopausal women., Visit 1 (screening)|Blood Glucose Level, Blood glucose level was measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)|Complete Blood Count (CBC), CBC was analyzed from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)|Blood Urea Nitrogen (BUN) Level, BUN level was measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)|Serum Creatinine Level, Serum creatinine level was measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)|Estimated Glomerular Filtration Rate (GFR), GFR was estimated from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)|Total Cholesterol Level, Total cholesterol level was measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening) and Visit 3 (during the trial, 4week±7day) Visit 4 (end of the trial) (12week±7day)|Urine pH, The pH level of urine was measured at Visit 1 (screening) using a dipstick method., Visit 1 (screening)|Urine Specific Gravity, The specific gravity of urine was measured at Visit 1 (screening) using a refractometer., Visit 1 (screening)|Urine Protein, The protein level in urine was measured at Visit 1 (screening) using a dipstick method., Visit 1 (screening)|Urine Glucose, The glucose level in urine was measured at Visit 1 (screening) using a dipstick method., Visit 1 (screening)|Urine Ketones, The ketone level in urine was measured at Visit 1 (screening) using a dipstick method., Visit 1 (screening)|Urine Blood, The presence of blood in urine was measured at Visit 1 (screening) using a dipstick method., Visit 1 (screening)|Urine Leukocytes, The presence of leukocytes in urine was measured at Visit 1 (screening) using a dipstick method., Visit 1 (screening)|Aspartate Aminotransferase (AST), Aspartate Aminotransferase (AST) levels were measured using blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Alanine Aminotransferase (ALT), Alanine Aminotransferase (ALT) levels were measured using blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Alkaline Phosphatase (ALP), Alkaline Phosphatase (ALP) levels were measured using blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Gamma-Glutamyl Transferase (GGT), Gamma-Glutamyl Transferase (GGT) levels were measured using blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Total Bilirubin, Total Bilirubin levels were measured using blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Serum Sodium (Na), Serum Sodium (Na) levels were measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Serum Potassium (K), Serum Potassium (K) levels were measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Serum Chloride (Cl), Serum Chloride (Cl) levels were measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|C-Reactive Protein (CRP), C-Reactive Protein (CRP) levels were measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Erythrocyte Sedimentation Rate (ESR), Erythrocyte Sedimentation Rate (ESR) levels were measured from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Triglycerides, Triglyceride levels were analyzed from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|High-Density Lipoprotein (HDL), HDL levels were analyzed from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)|Low-Density Lipoprotein (LDL), LDL levels were analyzed from blood samples (12 cc) collected after fasting for 8 hours., Visit 1 (screening), Visit 3 (during the trial, 4 weeks ±7 days), Visit 4 (end of the trial, 12 weeks ±7 days)