Abstract: OBJECTIVE: To evaluate the efficacy and safety of Traditional Chinese Medicine(TCM) herbs for tonifying Qi and kidney, and replenishing spleen on intermittent asthma in children aged 2 and 5 years.METHODS: A randomized, single-blind, placebo controlled trial was conducted. Children with intermittent asthma were enrolled and their baseline conditions were measured using a questionnaire. A total of 60 participants, aged 2 to 5, were randomized into either the treatment group(n = 40) or the placebo group(n = 20). The treatment group was treated with granules of TCM herbs for tonifying Qi and kidney, and replenishing spleen, and the placebo group was given placebo granules for 3 months.The number of asthma attacks was counted and TCM syndrome scores were measured at 1, 2, 3, 6, 9,and 12 months. The airway resistance and levels of eosinophil cationic protein for the two groups were observed before and after 3 months. The results were statistically analyzed.RESULTS: Compared with the placebo group, the number of asthma attacks significantly decreased in the treatment group(P < 0.05). For the treatment group, the TCM syndrome scores decreased after 1 and 2 months; there was also a significant difference in scores between the two groups(P < 0.05).The difference remained after the medicine was stopped for 9 months(P < 0.05). After the 3-month treatment, compared with the placebo group, the airway resistance decreased in the treatment group(P < 0.05). No adverse events were reported in the treatment group.CONCLUSION: The TCM herbs for tonifying Qi and kidney, and replenishing spleen reduced the number of intermittent asthma attacks, decreased the TCM syndrome scores, and reduced the airway resistance in the children aged 2 to 5.

Key words: Asthma, Child, preschool, Medicine, Chinese traditional, Reinforcing Qi and kidney, Strengthening spleen