Objective

2

To observe and evaluate the efficacy and safety of Ganduqing Granules in the treatment of common cold due to qi deficiency and pathogen invasion.

Method

2

A multi-center， randomized， double-blind， and placebo-controlled clinical trial was conducted. One hundred and twenty patients were randomly divided into an experimental group （

n

=60） and a control group （

n

=60）. Patients in the experimental group were treated with oral Ganduqing Granules， 6 g per time， 3 times per day， while those in the control group received placebo， 6 g per time， 3 times per day. After treatment for 5 successive days in both groups， the overall remission rate， total score of primary symptoms， total score of secondary symptoms， total score of all symptoms， time required for overall symptom remission， and therapeutic efficacy against traditional Chinese medicine （TCM） syndrome in the two groups were analyzed in both full analysis set （FAS） and per-protocol set （PPS）， followed by the evaluation of safety in the safety set （SS）.

Result

2

No drop-out was found in the experimental group， whereas 3 cases in the control group dropped out. After 5 days of treatment， the overall remission rate of the experimental group was significantly higher than that of the control group （

P

<

0.01）. The analysis in FAS and PDS revealed identical results. The experimental group was obviously better than the control group in improving the total scores of primary symptoms， secondary symptoms， and all symptoms （

P

<

0.01）. The analysis results in FAS and PDS were consistent. There was no significant difference in overall remission time between the two groups. The experimental group was remarkably superior to the control group in alleviating such symptoms as aversion to wind and cold， nasal congestion， runny nose， fatigue， shortness of breath， laziness to speak， dry throat， sore throat， cough， and expectoration （

P

<

0.05，

P

<

0.01）. The analysis results in FAS were the same as those in PDS. All the patients did not present with significant abnormalities in vital signs， blood routine test， or liver and kidney function tests after medication. There was no significant difference in the incidence of adverse events between the experimental group and the control group.

Conclusion

2

Ganduqing Granules effectively alleviate the symptoms of patients with common cold and shorten the course of disease， without inducing obvious side effects.