Objective To observe the effect of Yiaikang capsules on viral load, immunologic function and quality of life of patients with human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS). Methods A prospective randomized controlled clinical study was conducted, 118 patients with HIV/AIDS admitted to Department of Integrated Traditional Chinese and Western Medicine of Qinghai Fourth People's Hospital from July 2015 to February 2017 were enrolled, and they were divided into two groups by random digital table method, 59 cases in each group. The control group received highly active anti-retroviral therapy (HAART); while the treatment in combined Chinese and western medicine group was additionally given Yiaikang capsules on the basis of the therapy in control group, 5 capsules (0.5 g per grain,) once and 3 times a day for 12 months. The differences of World Health Organization HIV quality of life scale (WHOQOL HIV-BREF) score, CD4+, CD8+T-lymphocyte and viral load levels were compared between the two groups. Results After treatment for 12 months, the results of WHOQOL HIV-BREF scores in two groups were reduced significantly compared with those before treatment (P ＜ 0.05), and the degree of decrease of WHOQOL HIV-BREF score in combined Chinese and western medicine group was slower than that in control group (82.57±8.76 vs. 70.53±9.45, P ＜ 0.05). The CD4+, CD8+levels in control group after treatment were of no significant change compared with those before treatment (P ＞ 0.05), but the viral load level was decreased significantly after treatment compared with that before treatment (log/mL: 3.57±0.82 vs. 3.89±1.32, P ＜ 0.05); the CD4+in combined Chinese and western medicine group after treatment was obviously higher compared with that before treatment (number/μL: 413.67±187.39 vs. 376.65±206.51), the viral load level was markedly lowered compared with that before treatment (log/mL: 3.14±0.76 vs. 3.81±1.27) and the level of CD4+was significantly higher in combined Chinese and western medicine group than that in control group (413.67±187.39 vs. 382.72±194.82), viral load level in combined Chinese and western medicine group was siginificantly lower that in the control group (3.14±0.76 vs. 3.57±0.82, P ＜ 0.05), but the number of CD8+in two groups after treatment was of no significant change (P ＞ 0.05). Conclusion Yiaikang capsules possibly may elevate the number of CD4+T-lymphocytes and decrease the level of viral load to improve the quality of life in patients with HIV/AIDS.

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