Efficacy and Safety of Fermented Achyranthes japonica NAKAI Extract Powder on degenerative arthritis; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001958
- Lead Sponsor
- Bioland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
(1) All men and women aged between 40 and 75 year
(2) VAS(Visual Analogue Scale) = 30mm
(3) Kellgren-Lawrence Grade ? to ? confirmed radiologically
(4) Subject who agrees to participate in the study and signs the informed consent form
(1) Arthritis caused by other factors (Non-degenerative arthritis)
(2) Joint space narrowing (more than 2mm)
(3) Radiographic finding in moderate arthritis include marginal osteophyte formation, irregular joint margin, subchondral bone cyst
(4) Include clinically significant cardiovascular disease or immune disease or inflammatory disease or tumor disease
(5) Subject who complain gastrointestinal symptoms such as gastritis, gastric ulcer
(6) Subject with uncontrolled hypertension (over 170/100mmHg, when measuring after 10 minutes steady)
(7) Subject with uncontrolled diabetes mellitus (more than 180mg/dl of fasting glucose)
(8) Subject with TSH =0.1uU/ml or = 10 uU/ml
(9) Subject with AST(GOT) or ALT(GPT) or ?-GTP = 3 times the upper limit of normal
(10) Subject with serum creatinine = 2 times the upper limit of normal
(11) Subject who is pregnant or lactating, or plans to become pregnant within 3 months
(12) Subject who has taken medicines, health functional foods within 1 weeks for improvement of arthritis
(13) Subject with mental disorders such as schizophrenia, depressive disorder, drug intoxication
(14) Subject who participated in any clinical trial within 3 month or plan to participate in the other clinical study
(15) Inappropriate subject decided by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual analogue scale
- Secondary Outcome Measures
Name Time Method Korean-Short Form Health Survey 36;Korean-Western Ontario and McMaster University Osteoarthritis Index;generalized evaluation of physician;generalized evaluation of patient;CRP(C-Reactive Protein), ESR(Erythrocyte Sedimentation Rate)