Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.
* Meng Kun found that Joint application of Chuankezhi can enhance the number of CD4 cells and reduce side-effects of HAART compared with HAART alone. in order to verify the long-term efficacy of combination therapy, they carried out an clinical observations of three cases of patients who received combination therapy for over a period of 3 years, through the observation of three cases of patients, they found that CD3+CD4+T lymphocyte count were significantly increased and HIV-RNA viral load were below 50copies for long-term, and without the occurrence of drug resistance. And the patient's symptoms and signs have also been significantly improved. * Duan Cheng Yu analyses 334 cases of AIDS patients' clinical symptoms, signs and Karnofsky score, and CD3+CD4+ T lymphocyte count before and after treatment. The patients all take "kang ai bao sheng" capsules for 3 months. The results showed that 334 cases of patients receiving traditional Chinese and western medicine treatment shows improvement in symptoms and signs, increase in CD3+CD4+ T lymphocyte count. They proposed that combination of traditional Chinese and western medicine can improve symptoms, enhance immunity function and improve the quality of life of AIDS patients. * In order to observe the effect of combination of TCM and HAART on HIV/AIDS patients, ZHANG Ai-min divided 63 cases of AIDS into 3 groups. 20 cases received TCM treatment and 22 cases received combination of TCM and HAART, 21 cases received western medicine. The patients' symptoms, signs, Karnofsky score points, CD3+CD4+T lymphocyte counts and HIV-RNA viral load were recorded and compare the difference between the 3 groups. The results showed that combination treatment can more effectively improve the immune function of HIV/AIDS patients, reduce HIV-RNA viral load, and improve the patients' symptoms, signs and the quality of life. * Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity. * Through the clinical trials, we are going to evaluate the efficacy and safety of combination of TCM and HAART on immune reconstitution of HIV/AIDS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Immunity 1 (Fuzheng 1), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days. Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Jie, WANG
Beijing, Beijing Municipality, China
RECRUITINGPeripheral blood CD3+ CD4+ counts
Time frame: 6 months
Immune reconstitution efficiency
Time frame: 6 months
Viral load
Time frame: 6 months
Clinical symptoms and signs
Time frame: 6 months
KPS score
Time frame: 6 months
Quality of life score
Time frame: 6 months
Side effect of HAART
Time frame: 6 months
Safety evaluation
Time frame: 6 months
Economic evaluation
Time frame: 6 months
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