A human study of herbal complex extract NS2107 on climacteric symptoms in menopausal wome
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007206
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) Subjects who voluntarily agree to participate and signs informed consent form
2) Adults more than 50 years old
3) Subjects who suffer from knee osteoarthritis
1) Subjects who took nonsteroidal anti-inflammatory drugs(NSAID) or steroid-based medications within one week of the first visit
3) Inflammatory osteoarthritis (increase of ESR
4) BMI = 30
5) Other nervous system or lower limb abnormality such as hip joint or foot joint that can disturb gait
6) Surgery on knee joint
7) More than moderate degree of back pain or radiating pain in lower limbs
7) Severe neurological or vascular diseases in lower limbs
8) AST(GOT) or ALT(GPT) level over 3 times of the upper limit of normal range
9) Creatinine level over 1.5 times of the upper limit of normal range
10) Subject diagnosed with dementia or intellectual disability or who is illiterate
11) Continuous consumption of health functional food that affect osteoarthritis within 4 weeks before the first visit
12) Those who participated in other clinical trials within a month
13) Pregnant women or lactating women or persons planning to become pregnant
14) Subject who has hypersensitivity to ingredients contained in test food or placebo or has experienced severe food allergy reactions
15) Subjects who are deemed to be inappropriate to this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual analogue scale;Western Ontario and McMaster University Osteoarthritis Index
- Secondary Outcome Measures
Name Time Method Radiographic assessment;Biomarkers;Blood, urine test