Randomized, double-blind, placebo-controlled clinical trial of Jingu Zhitong Ningjiao in treatment of knee osteoarthritis with kidney deficiency and blood stasis
- Conditions
- knee osteoarthritis
- Registration Number
- ITMCTR2024000175
- Lead Sponsor
- The First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, China
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) Meeting the diagnostic criteria of KOA (refer to the 2018 edition of Osteoarthritis Diagnosis and Treatment Guidelines); 2) Kellgren LawrenceX classification was grade I to ?. 3) It meets the diagnostic criteria of TCM KOA with kidney deficiency and blood stasis (according to the 2018 edition of Guiding Principles for Clinical Research of New Chinese Medicine and 2018 edition of TCM Clinical Diagnosis and Treatment Terms · Syndrome Part); 4) Age 40-75 years old, gender is not limited; 5) Patients who voluntarily receive treatment and sign informed consent.
1) Patients complicated with knee joint tuberculosis, knee joint tumor, acute knee joint injury and other diseases; 2) Advanced KOA patients, knee space is obviously narrow or rigid; 3) Pregnant and lactating women; 4) Suffering from serious heart, lung, brain and blood system diseases; 5) Patients currently participating in other clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index;
- Secondary Outcome Measures
Name Time Method Knee range of motion;Cartilage thickness;visual analogue scale,VAS;Temperature difference before and after knee joint treatment;TCM syndrome integral;