Abstract： Objective： To observe the clinical effect and safety of the therapy of Guilingji capsules for senile frailty syndrome. Methods：A total of 24 patients with senile frailty syndrome were randomly selected. All patients were treated with Guilingji capsules，two capsules each time，0.6 g per capsule，once a day for 12 weeks. The patients were followed up after 6 and 12 weeks of treatment. Before and after treatment， the scores of vital signs， frailty symptoms， sleep quality and ability of daily living(ADL) of the participants were recorded. The related indexes， such as serum transferrin， vitamin B12， vitamin D， thyrotropin， superoxide dismutase， interleukin- 6， and six sex hormones， were detected， and the adverse reactions were observed. Results：After 12 weeks of treatment，the scores of Clinical Frailty Scale(CFS)，Pittsburgh Sleep Quality Index(PSQI) and ADL were decreased when compared with those before treatment，differences being significant(P＜ 0.05， P＜0.01)； the scores of Mini Mental State Examination(MMSE) were significantly increased， differences being significant(P＜0.01). After 6 and 12 weeks of treatment，the proportion of very mild frailty(Grade Four) was increased from 16.67% to 37.50% and 66.67% when compared with those before treatment，differences being significant(P＜0.05)；after 6 and 12 weeks of treatment，the proportion of mild frailty(Grade Five) was decreased from 83.33% to 62.5% and 33.33% when compared with those before treatment， differences being significant(P＜0.05). After 12 weeks of treatment， progesterone and vitamin D were significantly increased， differences being significant(P＜0.05， P＜0.01)； the IL- 6 was significantly decreased， the difference being significant(P＜0.05). There was no significant difference being found in the comparisons of serum transferrin， vitamin B12， thyrotropin， superoxide dismutase， testosterone， estradiol， luteinizing hormone， prolactin and follicle stimulating hormone before and after treatment(P＞0.05). During treatment， the curative effect of Guilingji capsules was relatively stable，and the incidence of serious adverse reactions was 4.17%. Conclusion：The therapy of Guilingji capsules can effectively improve the symptoms of patients with senile frailty syndrome，with good clinical effects and safety.