Background  The risk of acute mountain sickness (AMS) will increase without steps or hypoxic preconditioning training. AMS is a potentially fatal disease caused by acute hypoxia that can directly lead to trainee attrtion. Therefore, it is of great significance to actively conduct drug research and development to prevent AMS.

  Objective  To observe the protective effect of oral Danqijing granules on acute altitude sickness in people who quickly enter plateau area.

  Methods  A prospective, randomized, controlled clinical trial design was conducted to select 80 male officers and soldiers (18-35 years old) who participated in altitude training in June 2022, and they were randomly divided into treatment group and control group with 40 cases in each group. The treatment group was given Danqijing granules (mainly composed of Radix Astragalus, Salvia miltiorrhiza, Huangjing), while the control group was given Rhodiola Rosea capsules (mainly composed of Rhodiola Rosea), starting from 7 days before entering the plateau, for a total of 14 days. The general conditions of the two groups on day 1 (T1), day 3 (T2) and day 7 (T3) after admission to plateau were compared, including the TCM syndrome grading scale, AMS scale score, serum Tumor Necrosis Factor-α(TNF-α), Interleukin-6 (IL-6), Interleukin-8 (IL-8) levels and drug safety indexes.

  Results  There were no significant differences in systolic blood pressure (mmHg), diastolic blood pressure, heart rate, SpO₂ between the two groups at each time point (all P>0.05). The scores of TCM symptoms on day 7 decreased significantly compared with that on day 1 after the two groups were stationed at the plateau (P<0.05). Compared with the control group, the scores of TCM symptoms in the treatment group were less on day 7, but the difference were not statistically significant (P=0.088) . Compared with day 1, the levels of TNF-αand IL-6 in both groups were decreased on day 3 and day 7 (P<0.01), and the treatment group was greater than those in the control group (P<0.05). There were no significant differences in IL-8 level and AMS incidence between the two groups (P>0.05). Liver, kidney and other indicators were all normal.

  Conclusion  Danqijing granules can reduce the score of TCM syndrome grading scale and improve the clinical symptoms of patients who rush to plateau. It may reduce the serum levels of TNF-α and IL-6 to protect against AMS in people with acute altitude exposure.