| Objective: To observe the effect of Lianpu Granule (LPG) in treating common cold (Wind-Heat syndrome) and objectively evaluate its safety.Methods: Both clinical trials were behaved under the guide of good clinical practice (GCP). In the phase II, muticenter, double-blinded, double-dummy and controlled trial, 48 subjects with common cold (Wind-Heat syndrome) were randomized to receive LPG (n=24) or Compound Oral Liquid of Shuanghuanglian (COLSHL) (n=24); 80 subjects were involved in the phase III, muticenter randomized and double-blinded trial, who were divided into the LPG group (n=60) and COLSHL group (n=20). LPG was administered 8 g, three times a day, and COLSHL, 10 ml, three times a day. The therapeutic course for both group was 3 days.Results: In the treated group, the markedly effective rate was 80.95%, 81.67%, and effective rate was 95.24% and 98.33%; the markedly effective rate for TCM syndromes was 80.95%, 85.00%, and effective rate was 95.24% and 98.33%; the markedly effective rate for fever was 85.71% and 75.61%, and effective rate was 90.48% and 97.56% in the phase II and III respectively. Meanwhile in the controlled group, the markedly effective rate was 60.87%, 65.00%, and effective rate was 95.65% and 90.00%; the markedly effective rate for TCM syndromes was 60.87%, 65.00%, and effective rate was 95.65% and 85.00%; the markedly effective rate for fever was 86.96% and 76.92%, and effective rate was 95.65% and 100.00% in the phase II and IIIrespectively. There was no significant difference between LPG and COLSHL group in effective time, clinical effect, and effective rate for fever (all P > 0.05). No adverse effect was found during the observation.Conclusion: LPG shows a definite clinical effect in treating common cold (Wind-heat syndrome) with no obvious toxic-adverse effects. |