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Objective: To observe the effect of Qiju Dihuang Pill (QDP) on changes of Chinese medical syndrome types in pregnant women of Gan-Shen yin deficiency syndrome (GSYDS), and to explore the correlation between imbalanced cytokine levels and GSYDS., Methods: This was a random controlled trail. A total of 163 pregnant women of GSYDS at 12 -16 gestational weeks were randomly allocated into the experimental group (86 cases) and the control group (77 cases). Patients in the experimental group took QDP for 2 -4 weeks. Changes of Chinese medical syndrome types and serum interferon-gamma (IFN-gamma) and interleukin-4 (IL-4) levels were observed and compared between the two groups before and after treatment., Results: (1) Totally 41 patients (47.7%) in the experimental group were transformed to normal Chinese medical syndrome type. In the same period of the follow-ups, 9 patients (11.7%) in the control group were transformed to normal Chinese medical syndrome type, showing statistical difference (P < 0.05). (2) In the experimental group, the serum level of IFN-gamma and the ratio of IFN-gamma/IL-4 in the peripheral blood were obviously lower after treatment than before treatment (P < 0.01), and obviously lower than those in the control group (P < 0.01). The level of IL-4 after treatment in the experimental group was higher than that before treatment, and also higher than that in the control group, but with no statistical difference., Conclusions: These results indicated that there was imbalanced IFN-gamma/IL-4 ratio in the peripheral blood of pregnant women of GSYDS. QDP might play a role in immunoregulation by affecting the IFN-gamma level.