KCT0003124尚未招募未知
A 8-week, randomized, double-blind, placebo-controlled, investigator-initiated clinical trial to evaluate the efficacy and safety of GyejigaChulbu-tang on degenerative osteoarthritis
Wonkwang University, Gwangju Medical Center0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 .
研究者
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