Objective: To objectively evaluate the curative efficacy and safety of Nvshi oral liquid combined Yuening capsules in treating feminine yin deficiency symptom (FYDS) accompanied with primary insomnia (PI). Method: One hundred and twenty FYDS patients with PI were randomly divided into the experiment group (60 cases) and the placebo group (60 cases) by a multicenter

randomized

double blind and placebo-controlled method. Patients in the experiment group received 10 mL Nvshi oral liquids

and 1 Yuening capsule twice daily. Patients in the placebo group received placebo of sham liquids and capsules

the same usage and dosage as the experiment group. All patients in two groups received 8 weeks of treatment. The melioration of patients' FYDS was graded by Pittsburgh sleep quality index (PSQI). Result: The total transformational scores of FYDS in the experiment group were lower than those in the placebo group during and after the interferential treatment (P<0.05

P<0.01)

and there was statistical significance for the difference between two groups. The results of the experiment group were better than those of the placebo-controlled group (P<0.01). Scores of palm fever

dry skin and oral lips

oral color red

dry eyes

constipation and dry mouth to drink were lower (P<0.05

P<0.01)

score of PSQI was lower (P<0.01)

integral calculus value was higher (P<0.01) in the experiment group than those in the placebo group. After interferential treatment

scores of sleep quality

sleep latency

sleep time

sleep efficiency

sleep disorders and daytime dysfunction were less than those in the placebo group (P<0.01). No obvious abnormal safety indicators in heart

liver and kidney function were found. Conclusion: Nvshi oral liquids combined Yuening capsules could ameliorate eminine FYDS and sleep quality

and it has good safety in treating patients.