None listed
Conditions
Interventions
Drug : Participants who met the inclusion criteria are randomised to experimental group(GyejigaChulbu-tang group) or control group(placebo group).
-Experimental group: GyejigaChulbu-tang, 3 times/day(
Sponsors
Wonkwang University, Gwangju Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 50 to 80 years old 2. A person who diagnosed primary osteoarthritis on American college of rheumatology criteria a. A person who currently has pain in on or both knees b. Person who over at least three of the following sis criteria 1) Age: 50 to 80 years old 2) A person who knee joints are not more than 30 minutes stiffness in the morning 3) Crepitus of knee joint 4) Bony tenderness 5) Bony enlargement 6) No palpable warmth 3. A person who 100mm VAS(visual analogue scale) pain is more than average 40 points per day (for a week) 4. Agreed with written informed consent voluntarily
Exclusion criteria
Exclusion criteria: 1. A person who had a steroid injection in the joint cavity (screening test ~ 4 week) 2. A person who received an viiscosupplement(hylan, sodium hyaluronate, hyalulonan etc.) injection in the joint cavity (within 6 months before screening test) 3. A person who eliminated to expel joint fluid from joint cavity (within 3 months before screening test) 4. A person who received a new non-steroidal anti-inflammatory drug (within 4 weeks before screening) or modified capacity(within 2 weeks before screening test) 5. A person who experienced to use biological preparation or cytostatic before screening test 6. A person who experienced to use immunomodulator or immunosuppressant (within 6 months before enrollment or now) 7. A person suffering from a serious illness (inflammatory disease, multiple sclerosis, connective tissue disease, cancer, RA, Autoimmunkrancheit etc.) 8. A person who has had stomach problems or surgery that could affect clinical test.(ex., Crohn's disease, but excluding appendicitis surgery and hernia surgery) 9. Those who participate in other clinical studies. 10. A person who experienced to Antipsychotics treatment (within 2 months before screening test) 11. Those who have a history of drug or alcohol abuse 12. Female patients who are pregnant or breastfeeding 13. Patients with positive findings in the urine pregnancy test before random assignment, patients who are unable or unwilling to use appropriate contraceptive methods 14. Those who received treatment due to liver or kidney function disorder 15. Those who were considered as unsuitable for participation by the researcher .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of 100mm VAS (visual analog scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of subjects whose 100mm VAS(visual analog sclae) has decreased by more than 50 percent from the baseline;K-WOMAC(Korean Western Ontario and McMaster Universities Questionnaire) total score & subscore;SF(Short-Foam)-36 health survey;Patient's Global Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Kwon
Wonkwang University, Gwangju Medical Center
Outcome results
None listed