AUTHOR=Lv Yubao , Wei Ying , Abduwaki Muhammadjan , Jurat Tohti , Li Fengsen , Wang Huaizhen , Wu Yuhua , Li Zheng , Liu Bo , Yin Hongjun , Cao Yuxue , Nurahmat Mammat , Tang Zihui , Dong Jingcheng 

TITLE=A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Loki zupa in Patients With Chronic Asthma

JOURNAL=Frontiers in Pharmacology

VOLUME=9

YEAR=2018

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2018.00351

DOI=10.3389/fphar.2018.00351

ISSN=1663-9812

ABSTRACT=<p>The purpose of this study was to evaluate the efficacy and safety of Uyghur medical formula Loki zupa in patients with chronic asthma. Adult patients with chronic asthma randomly received placebo or Loki zupa as add-on to inhaled corticosteroids (ICS) maintenance treatment. Loki zupa or mimics was administered orally 10 ml per time, three times a day for 8 weeks. The primary endpoints were asthma control test (ACT) score and peak expiratory flow (PEF). The secondary endpoints were acute exacerbation rate, lung function, night waking days, and symptom-free days in the near 2 weeks, Asthma Quality of Life Questionnaire (AQLQ) score and some inflammatory cytokines in peripheral blood. A total of 240 adult patients with chronic asthma were enrolled, and 218 patients were randomized to placebo (<italic>n</italic> = 109) or Loki zupa (<italic>n</italic> = 109) in addition to ICS for 8 weeks. Treatment with Loki zupa resulted in significant improvement in ACT score compared to the placebo group (<italic>p</italic> = 0.002). Furthermore, oral taken of Loki zupa increased the PEF obviously (<italic>p</italic> = 0.026). Loki zupa treatment did not improve the forced expiratory volume in 1 s (FEV<sub>1</sub>, <italic>p</italic> = 0.131) and FEV<sub>1</sub>/FVC compared to the placebo treatment (<italic>p</italic> = 0.805). The placebo group had higher rates of acute exacerbations than the Loki zupa group (6.3% vs. 0, <italic>p</italic> = 0.027). Subjects randomized to Loki zupa had increased daytime symptom-free days within 2 weeks than placebo (<italic>p</italic> = 0.016). However, Loki zupa had no effect on night waking days in the near 2 weeks (<italic>p</italic> = 0.369) and AQLQ score (<italic>p</italic> = 0.113). No significant effect was found on inflammatory cytokines (IL-2, IL-4, IL-5, IL-10, IL-13, IL-17, IL-33, IFN-γ, and TGF-β) between the two groups (<italic>p</italic> &gt; 0.05). No adverse events and severe asthma exacerbations were recorded in the two groups (<italic>p</italic> &gt; 0.05). Loki zupa add-on to standard ICS produced clinically significant improvements in ACT score, PEF, daytime symptom-free days and acute exacerbation in patients with chronic asthma.</p><p><bold>Clinical trial:</bold> This study is registered at <ext-link ext-link-type="uri" xlink:href="http://www.chictr.org.cn/" xmlns:xlink="http://www.w3.org/1999/xlink">http://www.chictr.org.cn/</ext-link> with identifier number ChiCTR-IPR-16008106.</p>