Objective:To assess further the effect and safety of Compound Watermelon Frost Eye Drops in treating asthenopia syndrome (Syndrome of stagnated heat of lungs and stomach)Methods:Establish the standards of quality control, executing the quality control at the aspects of researchers, the observation indexes and subjects. Divided the patients who diagnosed with asthenopia syndrome (Syndrome of stagnated heat of lungs and stomach) into test group (360 patients) and control group (120 patients) by randomized, double-blind controlled, parallel controlled, placebo controlled and Multicentre clinical studied. The proportion of two groups is 3:1. The test group was treated with Compound Watermelon Frost Eye Drops and the control group was treated with NS eye drops, evaluated the before and after clinical symptoms, effects and the indexes of safety, etc. after the 2 weeks treatment.Results:1. General effect:After the treatment, the recovery and obvious effect rate of control group was 25.22% and general effective rate was 48.70%; the recovery and obvious effect rate of test group was 60.68%, and general effective rate was 89.74%. there was statistically significant difference between the two groups (P<0.05).2. The time of close visual work:After the treatment, the time of close visual wok was 37.71±13.53 minute in the control group and 47.15±15.32 minute in the test group. There was statistically significant difference between the two groups (P<0.05).3. Symptoms:Compared the total scores of clinical symptoms of Chinese and western medicine, there was no statistically significant difference between two groups in the symptoms scores before the treatment (P>0.05), but the total scores of clinical symptoms of Chinese and western medicine have declined after the treatment (P<0.05). After the treatment of two groups, there was statistically significant difference in each symptom (P<0.05) except bitter taste (P=0.3802).4. Safety analysis:The results of routine blood test, routine urinary test, routine stool test, liver function test, kidney function test and ECG test of patients are normal before and after treatment, which indicates Compound Watermelon Frost Eye Drops is effective, safe, non-toxic and no adverse effect under this experiment condition.Conclusion:Compound Watermelon Frost Eye Drops is effective and safe in treating asthenopia syndrome (Syndrome of stagnated heat of lungs and stomach), which could prolong the time of close visual work and improve the clinical symptoms evidently. It is safe and effective for clinical application. It is worth further researching and wide spreading to clinical application.
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