12 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of YD-106AS on Osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002349
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse Reactions, Clinical Laboratory, electrocardiogram ;Clinical Laboratory ;electrocardiogram ;Vital Sign(Pulse, Blood Pressure), Weight