[An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine [corrected] hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold].Zhonghua Nei Ke Za Zhi 2002; 41(8):547-9ZN
To evaluate the efficacy and safety of compound pseudoephedrine [corrected] hydrochloride (New Contact sustained release capsules) in the treatment of the nasal symptoms associated with common cold or influenza.
Open label multi-center clinical trial was adopted: one capsule twice daily with an interval of 12 hours, successively for 4 days to treat the nasal symptoms associated with common cold or influenza.
A total of 416 patients were eligible for efficacy and safety analysis. The cure rates for nasal congestion from day 1 to day 4 were 7%, 31%, 64% and 88%, cumulatively; for runny nose were 9%, 36%, 68% and 89%; for sneezing were 20%, 51%, 76% and 93%, and for watery eyes were 36%, 68%, 89% and 96%, respectively. There were no serious adverse events during the study. Forty adverse events (AE's) with an incidence of 8% were developed in 35 patients. The most frequent AE's were drowsiness (24/416, 6%) and dry mouth (5/416, 1%). All AE's were in mild or moderate degree.
The results indicated that New Contact sustained released capsule was effective in controlling the nasal symptoms associated with common cold or influenza and it was well-tolerated.