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• The aim of the present study was to analyze the clinical effect of Qing Yi Tiao Mian (QYTM) formula on unexplained recurrent spontaneous abortion (URSA) during early pregnancy and on the immune balance of T lymphocytes. • 45 patients with URSA in 4th-9th week of pregnancy were separated into three groups: conventional fetal protection group (n=15), prednisone treatment group (n=10) and QYTM formula treatment group (n=20). These patients would get the treatment once they were diagnosed with an intrauterine pregnancy. The conventional fetal protection group was given progesterone (an injection of 20 ∼ 40 mg daily) for four weeks. The prednisone treatment group was given progesterone (an injection of 20 ∼ 40 mg daily) +prednisone (5 mg/d) for four weeks. The QYTM formula treatment group was given progesterone (an injection of 20 ∼ 40 mg daily) + QYTM formula (one dose per day) for four weeks. In addition, the women who had previously had a normal pregnancy have been enrolled as a control group (n=18). The success rate of the pregnancy in the first trimester was observed in each group, and the proportion of T lymphocytes in the peripheral blood before and after treatment was recorded. • QYTM formula significantly decreased the spontaneous abortion rate in URSA patients during early pregnancy. The mechanism may be closely related to the inhibition of the proliferation of killer lymphocytes represented by CD8+T lymphocytes and natural killer (NK) cells. The present study aims to analyze the clinical effect of the Qing Yi Tiao Mian (QYTM) formula on unexplained recurrent spontaneous abortion (URSA) during early pregnancy and the immune balance of T lymphocytes. With their consent, 45 patients with URSA in weeks 4–9 of pregnancy were separated into three groups, i.e., the conventional fetal protection (n = 15), prednisone treatment (n = 10), and QYTM formula treatment (n = 20) groups. These patients received treatment once they had been diagnosed with an intrauterine pregnancy. The conventional fetal protection group was given progesterone (20 ∼ 40 mg daily injection) for four weeks. The prednisone treatment group was given progesterone (20 ∼ 40 mg daily injection) + prednisone (5 mg/d) for four weeks. The QYTM formula treatment group was given progesterone (20 ∼ 40 mg daily injection) + QYTM formula (one dose per day) for four weeks. In addition, women who had previously had a normal pregnancy were enrolled as a control group (n = 18). The success rate of the pregnancy in the first trimester was observed in each group, and the proportion of T lymphocytes in the peripheral blood before and after treatment was recorded. Among the 20 patients with URSA in the QYTM formula treatment group, 19 remained pregnant. Thus, the success rate during early pregnancy was 95%, which was significantly higher than the conventional fetal protection (53.33%) and prednisone treatment (70%) groups. The CD8+ T and natural killer (NK) cells population in the URSA groups was higher compared with the control group (P < 0.01). The QYTM formula treatment significantly decreased the ratio of CD8+ T lymphocytes (P < 0.01) and NK cells (P < 0.01). The QYTM formula significantly decreased the spontaneous abortion rate in patients with URSA during early pregnancy. The mechanism may be closely related to the inhibition of the killer lymphocytes' proliferation by CD8+ T lymphocytes and NK cells. [ABSTRACT FROM AUTHOR]