Background and aim: Presently, over-the-counter drugs that can treat upper respiratory tract infections (URTI) are rarely effective and safe. Chaiqin Qingning Capsule (CQQNC), a Chinese patent medicine, which has been verified by long-term clinical practice is recommended by Chinese experts for the treatment of URTI with fever. This study conducted a prospective, double-blinded, randomized, multicenter controlled trial to evaluate the effectiveness and safety of CQQNC in the treatment of URTI.
Methods: The study was conducted at 4 clinical centers in China. Eligible subjects were recruited and randomized 1:1 to the CQQNC group and Qingkailing Capsule (QKLC) group. Both groups were administered orally three times a day for three consecutive days. Primary outcomes were the antipyretic onset time and the temperature recovery time. Secondary outcomes included the symptom disappearance rate, symptom score, and drug safety assessment.
Results: A total of 269 subjects were analyzed (134 subjects in the CQQNC group, 135 subjects in the QKLC group). The antipyretic onset time and the temperature recovery time were significantly shortened in the CQQNC group (median: 5 h vs. 10 h, p < 0.0001, median: 19 h vs. 27 h, p < 0.0001). CQQNC was more effective than the QKLC in improving the symptoms of pharyngodynia and rhinobyon (85.07% vs. 71.11%, p = 0.008; 76.99% vs. 64.41%, p = 0.043), and in improving the overall symptom scores (-15.10 ± 3.23 vs. -13.35 ± 3.58, p < 0.0001). During the trial, no serious adverse events were reported in the two groups.
Conclusion: CQQNC is effective and safe in the treatment of URTI with fever, and worthy of clinical application. (http://www.chictr.org.cn, ChiCTR-IPR-16009049).
Keywords: Chaiqin Qingning Capsule; Chinese patent medicine; Common cold; Fever; Randomized controlled trial; Upper respiratory tract infection.
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