None listed
Conditions
Interventions
Dietary Supplement : The participants enrolled in this study was assigned to 2 groups by double-blind randomization
Test group: YD-106AS bid, 4 Tablets per day
Placebo group: placebo 1 bid, 4 Tablet
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male and female aged between 40 years and 75 years 2) Subject with 30 mm or greater on VAS(Visual Analogue Scale) 3) Subject with Kellgren and Lawrence grade I or II on knee or hip joint 4) Subject who signed an informed consent form prior to the study
Exclusion criteria
Exclusion criteria: 1) Subject with other than degenerative arthritis determined by investigator 2)Subject whose joint space is less than 2mm 3) Subject with moderate arthritis accompanied by bone spurs around joint, irregular articular surface, chondrogenesis, and bone cyst 4) Subject with clinically significant cardiovascular, immunization, infective, or neoplastic diseases 5) Subject being treated for gastritis or gastric ulcer 6) Subject with uncontrolled hypertension (over 160/100mmHg measured at screening) 7) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose measured at screening) 8) Subject with TSH = 0.1 µIU/ml or = 10 µIU/ml 9) Subject with AST(GOT) and ALT(GPT) = 3 times the upper limit of normal 10) Subject with Creatinine = 2 times the upper limit of normal 11) Subject who is pregnant or planning to pregnant within 3 months 12) Subject administered medication or health functional foods related to arthritis within 1 week of screening 13) Subject administered medicinal herbs or foods containing of main components of Perilla frutescens and Atractylodes macrocephala Koidzumi within 1 week of screening 14) Subject with severe mental illness 15) Subject planning to participate in the other clinical trial 16) Subject participated in any clinical trial within 3 month 17) Inappropriate subject decided by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survey VAS;Korean - Western Ontario McMaster Universities Osteoarthritis (K-WOMAC) ;Korean-Short Form Health Survey 36(KSF-36);improvement of patients and investigator ;Inflammation of blood | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Reactions, Clinical Laboratory, electrocardiogram ;Clinical Laboratory ;electrocardiogram ;Vital Sign(Pulse, Blood Pressure), Weight | — |
Countries
Korea, Republic of
Contacts
Public ContactBongCheol Gwon
Hallym University Medical Center
Outcome results
None listed