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A comparative randomized double-blind clinical trial of hexapneumine and clistine as antitussive agents.


The efficacy and safety of a new antitussive expectorant drug hexapneumine was compared with that of an already marketed and functionally related clistine in a double-blind, randomized, parallel design clinical trial. A total of 100 patients with cough associated with chest diseases participated in the trial. Five patients (hexapneumine 3 and clistine 2) were lost to follow-up. Ninety-five patients (hexapneumine 46, clistine 49) completed the trial. Hexapneumine was significantly more effective (p less than 0.02) than clistine in suppressing cough as recorded from the patient's subjective improvement in the severity of the symptom. The side-effects observed were mild in nature and did not require reduction in dosage or withdrawal of the drug in any of the patients. Drowsiness and dryness of mouth were the predominant side-effects and were relatively more common in the clistine group as compared to hexapneumine. In the experimentally induced cough in 8 healthy human volunteers subjected to crossover design of study at weekly interval, hexapneumine and clistine were equally effective in suppressing cough. It is concluded that hexapneumine is a more effective antitussive as compared to clistine in naturally occurring cough. However, in experimentally induced cough the two drugs were equally effective. Hexapneumine exhibited relatively fewer side-effects.

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