Clinical Observation And Therapeutic Evaluation Of Anti-inflammatory Qudu Capsule In The Treatment Of Common Cold(wind-heat Syndrome)

Anti-inflammatory Qudu capsule is belong to fifth class drug.A randomized,effectiveness and safety of parallel control clinical study of anti-inflammatory Qudu capsule in the treatment of common cold(wind heat syndrome)was performed.Anti-inflammatory Qudu Capsule is prepared from effective fraction of Radix Satirist.There were no obvious toxic reaction acute toxicity in mice and long-term toxicity in dog.Anti-inflammatory Qudu Capsule had no significant effect on blood pressure,ECG,heart rate,respiratory frequency and amplitude of the anesthetized dogs in the general clinical pharmacology research.The cold(wind heat syndrome)patients were treated in a 3 day period,and they are randomized to 3 groups—the experimental group,positive control group and placebo group.Test group: 3 anti-inflammatory Qudu capsules + 1 bag /one time of simulation of Fufang Banlangen Granules,,3 times a day;Positive control: 3 simulation of anti-inflammatory Qudu capsules + 1 bag / one time of Fufang Banlangen Granules,,3 times a day;the placebo group: 3anti-inflammatory Qudu capsules + 1 bag / one time of simulation of Fufang Banlangen Granules,3 times a day.The positive control group is Fufang Banlangen Granules in this clinical trial,which is based on pharmacological effects that are consistent with clinical drug.Fufang Banlangen Granules' s main function is to clear heat and eliminate toxins;Fufang Banlangen Granules is commonly used medicine for clinical treatment of influenza.During this study,patients with fever need to measure the body temperature before treatment.Patients whose body temperature rise after the first dose need to measure body temperature every hour,4 times continuity.Subsequently,the body temperature of these patients was measured daily 10:00,14:00,20:00.The patients who have normal body temperature need to measure daily 14:00 once a day.The patients need to record the TCM syndrome score and do laboratory tests before and after administration at every visit.There was no abnormal in vital signs(systolic blood pressure and diastolic blood pressure,heart rate and respiratory rate)of various subjects after administration.The abnormal rate of laboratory results in the experimental group was similar to Fufang Banlangen Granules group and the placebo group.After 3 days of treatment,the main curative effect index of Anti-inflammatory Qudu Capsule is higher than that of Fufang Banlangen Granules group and placebo group and the total symptom score is lower.The Clearance rates of fever and pharyngalgia of Anti-inflammatory Qudu Capsule are higher than that of placebo group.The Clearance rates of snot and perspiration of Anti-inflammatory Qudu Capsule are higher than that of Fufang Banlangen Granules group.The onset time and antipyretic time of Anti-inflammatory Qudu Capsule are shorter than that of placebo group.In conclusion,based on the main index of the curative effect(the clinical efficiency of judgment),anti-inflammatory Qudu Capsule is better than Fufang Banlangen Granules and placebo.The safety of anti-inflammatory Qudu capsule is similar to Fufang Banlangen Granules and placebo.