Efficacy and Safety of Ganduqing Granules in Treating the Common Cold: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Author:

Wang Yilan1ORCID,Zhou Piao1,Wu Yuxiao1,Cao Huaqin2,Hao Wenfeng1,Wang Fei1ORCID,Guo Jing1ORCID

Affiliation:

1. Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan, China

2. Community Health Service Center of Simaqiao, Chengdu 610084, Sichuan, China

Abstract

Background. There is no clear evidence-based medicine that points to the most effective drug treatments for the common cold. In view of its ability to relieve symptoms and shorten the disease course, as well as its minimal side effects, traditional Chinese medicine (TCM) has been widely used to treat the common cold. However, there is a lack of strong evidence to support the clinical efficacy of TCM. This study aimed to evaluate the efficacy and safety of Ganduqing granules in the treatment of the common cold based on the network pharmacology analysis. Methods. In this multicenter, randomized, double-blind, placebo-controlled trial, 60 eligible subjects will be randomly assigned to either the intervention group or the placebo group. The intervention group will be treated with Ganduqing granules, while the placebo group will be treated with placebo. After 5 days of intervention, the efficacy and safety of Ganduqing granules in the treatment of the common cold will be observed. The primary outcome is the time to clearance of all symptoms. The secondary outcomes included the levels of IL-6, TNF-α, SOD, and MDA in the peripheral blood, time to disappearance of primary symptoms and secondary symptoms, clinical symptom remission rate, and change in TCM syndrome score. Results. Sixty participants completed the study. Ganduqing granules showed a greater effect on the time to clearance of all symptoms P < 0.0001 , nasal discharge P = 0.0124 , fatigue and lack of strength P = 0.0138 , dryness of the pharynx P < 0.0001 , pharyngalgia or dysphagia P < 0.0001 , and expectoration P < 0.0431 compared with the placebo group. Participants in the intervention group had a greater decrease of IL-6 levels compared with the placebo group P < 0.007 ; similar results were observed for the SOD P < 0.033 . However, the change in TNF-α and MDA levels in the intervention group was not significantly different from the placebo group. In addition, participants in the intervention group had a greater decrease of TCM syndrome score compared with the placebo group P < 0.040 . Conclusion. Ganduqing granules could improve common cold symptoms, shorten the disease course, attenuated inflammation and oxidative stress, and provided objective evidence for the efficacy and safety of a Chinese herbal medicine in treating the common cold.

Funder

Department of Science and Technology of Sichuan Province

Publisher

Hindawi Limited

Subject

Complementary and alternative medicine

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