Abstract： Objective： To observe the clinical effect of Jianpi Gushen Soft Extract on chronic fatigue syndrome of qi deficiency constitution. Methods：A total of 120 patients with chronic fatigue syndrome of qi deficiency constitution were divided into the control group and the intervention group according to the random number table method， with 60 cases in each group. Both groups received health education. In addition，the control group was treated with Oryzanol，and the intervention group was treated with Jianpi Gushen Soft Extract. The clinical effects in the two groups were evaluated； the scores of 20-Item Multidimensional Fatigue Inventory (MFI-20)，36-Item Short Form Health Survey (SF-36) and qi deficiency constitution were compared before and after treatment between the two groups. The levels of immunoglobulin (Ig) A ，IgG，IgM and complements C3 and C4 were detected before and after treatment in the two groups， and the safety was evaluated. Results： After treatment， the total effective rate was 66.67% in the intervention group， higher than that of 10.00% in the control group (P＜0.05). After treatment， the levels of IgA， IgG， IgM， C3 and C4 in the intervention group were increased when compared with those before treatment， and the above five levels were higher than those in the control group (P＜0.05). After treatment， the MFI-20 scores in the two groups were reduced when compared with those before treatment， and the MFI-20 score in the intervention group was lower than that in the control group (P＜0.05). After treatment， the score of qi deficiency constitution in the intervention group was lower than that before treatment，and the above score was lower than that in the control group (P＜ 0.05). After treatment，the scores of each field and total score of SF-36 in the two groups were elevated when compared with those before treatment (P＜0.05)， and the above scores in the intervention group were higher than those in the control group (P＜0.05). Conclusion：Jianpi Gushen Soft Extract can regulate the immune function of patients with chronic fatigue syndrome of qi deficiency constitution， improve the related clinical symptoms and physical status，and improve the quality of life.