Abstract: AIM: To evaluate the therapeutic effect, safty and tolerance of Shenguolaonianganmao Granules in the treatment of elderly and fragile patients suffering from common cold(Qi-deficiency and Lung-heat Syndrome).METHODS: The clinical trial was designed multicentered, double blind, randomized and parallel. A total of 240 elderly and fragile patients with common cold were randomly divided into two groups: a trial group (120 patients) were treated with Shenguolaonianganmao Granules, while a control group (120 patients) were treated with Yinqiaojiedu Granules. The therapeutic course of both groups was 3 days.RESULTS: The clinical trial include 228 patients was completed,105 in trial group and 104 in control group. The total effective rate of the trial group were 97.39%, while it of the control group were 91.15%,the comparison showed that the trial group achieved better therapeutic effect than the control group; The marked effective rate of the trial group were 80%, while it of the control group were 67.26%, the comparison showed that the trial group achieved better therapeutic effect than the control group (P<0.05). Each symptom was improved after treatment. The trial group received better effect than control group in relieving inactive talking and extremities soreness symptom(P<0.05). The trial group received better effect than control group in relieving fever, headache, sore throat, sweating, cough, fatigue, aversion of wind and coldness symptom, but there was no significant statistical difference in both groups(P>0.05). Only one patient in trial group had an adverse event(bruises of the right hand) during the treatment, but it is not caused by Shenguolaonianganmao Granules.CONCLUSION: The results show that Shenguolaonianganmao Granules has a definite effect on elderly and fragile patients with common cold (Qi-deficiency and Lung-heat Syndrome) with good safety.

Key words: Shenguolaonianganmao Granules, Elderly and fragile patients with common cold, Randomize controlled trial, Double blinded, Multi-centre