The 505 Shen Gong knee guard is a Chinese medicine health-care product for external use of knee that is specially developed based on the rheumatism and ¡°treating the internal disease from outside¡± theory of Chinese medicine industry, with reference to the prevention and treatment experiences about knee rheumatism and on the basis of clinical practice; this product is characteristic of reasonable formula, complies with the basic theory of Chinese medical industry, and has the functions such as expelling wind and clearing away cold, promoting the blood circulation, activating the blood and strengthening the muscles and bones. The toxicology experiment proves that, if 30g of product per kg is used outside the skin, there is no toxicity, cutaneous anaphylaxis and irritation to the skin. The pharmacodynamics experiment proves that the product has the anti-inflammatory, analgesia and promoting blood circulation and removing blood stasis functions. Three province-level clinical units from Shaanxi and Shandong, etc have made the clinical observation of 366 and 417 instances respectively, and the results indicate that this product has the obvious treatment effects on the swelling, pain, uncomfortable flexion and extension caused by rheumatic disease, rheumatic arthritis and soft tissue damage, strain, etc as well as the pain, heaviness, anesthesia and limited activity of knee and lower extremity caused by the wind, cold and humidity. The marked effect rate is 61.39%, and the total effective rate is 91.37%. We have found that there are no toxicity and important adverse effects. The clinical experiment studies indicate that the product may make the temperatures of some key points in the knee, this area and the surroundings obviously increase, the micro-circulation be obviously improved and local blood circulation be improved.
The process and quality standards of this product are practical. According to the inspection about three batches of samples by Shaanxi Provincial drug administration department, this product complies with relevant regulations of quality standards and has the good stability.
This study subject is of the realistic significance, and is characteristic of reasonable design, complete materials and systems and reliable data. Especially, the modern technologies such as the thermal infrared imager, laser micro-circulation blood flow meter and impedance blood drawing, etc have been successfully used for the clinical experiment study and mechanism discussion. The study has used the advanced methods, employed the novel thoughts, enjoyed the originality, and seemed very scientific and persuasive. Therefore, this comprehensive study results have taken the leading place in the similar project studies at home and abroad.
This product is safe, effective, simple and practical. It has the treatment and health-care functions and also has the promotion and application values, so it¡¯s expected that it will bring the social benefits and economic benefits.
We suggest that this product should be applied for the production approval from health administration department and for science advancement award.
Health Bureau of Shaanxi Province
Medicine Administrative Bureau
of Shaanxi Province
Shaanxi Society and Technology
Technical Leaders of Appraisal:
Traditional Medicine Consultant of WHO
Standing Committee Member of China
Society and Technology Association
Vice Chairman of China Association of
Combination of Traditional Chinese
Medicine and Western Medicine
Vice Chairman of Geriatrics Society ofChinese Medical Association