Process optimization of compound cotton rose hibiscus leaf ointment and its clinical efficacy and safety verification / 中国组织工程研究

ABSTRACT

BACKGROUND: Compound cotton rose hibiscus leaf ointment is developed from the continuous optimization of the preparation process of traditional famous prescription "Xiaozhong San". Xiaozhong San has been used in Ruijin Hospital Affiliated to School of Medicine of Shanghai Jiaotong University for over 40 years and has achieved good clinical outcomes. OBJECTIVE: To verify the clinical efficacy and safety of compound cotton rose hibiscus leaf ointment, laying a foundation for its popularization and application in the treatment of acute soft tissue injury. METHODS: 112 cases of acute soft tissue injury were divided into trial group (n=55) and control group (n=57) according to the random number table method. The experimental group selected the compound cotton rose hibiscus leaf ointment, and the control group selected the compound Zijing ointment. RESULTS AND CONCLUSION: (1) There were no statistical differences in the primary outcomes, such as pain, tenderness, swelling, dysfunction and in the secondary outcomes, such as ecchymosis, insomnia, dry mouth, constipation, tongue coating and pulse condition, between the two groups before treatment, at 3 and 7 days of treatment and after treatment termination (P> 0.05). (2) The two groups achieved obvious clinical outcomes in the treatment of acute soft tissue injury, but there was no difference in the clinical efficacy between the two groups (P> 0.05). (3) The two groups had no obvious abnormalities in the routine of hematuria and stool and the function of the liver and kidney. (4) There were only five cases of mild skin allergy, including two cases in the trial group and three cases in the control group. To conclude, the compound cotton rose hibiscus leaf ointment has good clinical efficacy and safety, which is worthy of clinical application.