A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild Osteoarthritis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004925
- Lead Sponsor
- The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
1)Male or female adults aged between 35 and 70 years of age.
2)Subjects with a visual analog scale (VAS) score of more than 30 mm
3)Subjects with Kellgren and Lawrence grade I or II determined by X-ray
4)Subjects who agree to participate in the clinical trial voluntarily and sign the informed consent form (ICF)
1)A person who has arthritis other than osteoarthritis.
2)A person whose joint space is less than 2 mm.
3)A person with moderate osteoarthritis accompanied by osteoporosis, irregular joint surface, subchondral osteocytes of the joint and so on.
4)Those who have clinically significant cardiovascular, autoimmune, infectious or neoplastic diseases in addition to joint pain.
5)Hypertension patients with more than 160mmHg systolic blood pressure or more than 100mmHg diastolic blood pressure.
6)Diabetic patients whose fasting blood glucose level is above 180 mg / dl).
7)TSH lower than 0.1µIU/ml or upper than 10 µIU/ml
8)A person who has AST (GOT) or ALT (GPT) level 3 times higher than the normal upper limit.
9)Abnormal creatinine level (more than twice the normal upper limit).
10)Those who have taken arthritis medicines or dietary supplements for joint health within 2 weeks of visit.
11)Subjects who have taken physical or herbal therapies (acupuncture, depression, moxibustion, etc.) for degenerative bone disease within 2 weeks of visit.
12)Subjects who participate in other intervention trials within two months of visit 1 or plan to participate in other intervention trials after the after the commencement of this study.
13)Women who are pregnant, lactating, or planning to become pregnant within three months.
14)A person with mental illness or drug addiction or who is under anti-depression treatment.
15)A person who is sensitive or allergic to food ingredients.
16)A person who has trouble or difficulties participating in the trial as judged by the investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total score and score of each item of Osteoarthritis Symptom Assessment(K-WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index )
- Secondary Outcome Measures
Name Time Method Pain Index Evaluation(VAS: Visual analogue scale);Health level measurement tools(SF-36: Short form health survey 36);Investigator's improvement evaluation;Subject's improvement evaluation