Incomplete immune reconstitution in HIV infection
Conditions
Interventions
Wenshen Jianpi treatment group:Wenshen Jianpi Granules plus ART
Wenshen Jianpi Control Group:Antiretroviral Therapy
Yiqi Jianpi treatment group:Yiqi Jianpi Granules plus ART
Yiqi Jianpi Control Group:Antiretroviral Therapy
Yangxin Jianpi treatment group:Yangxin Jianpi Granules plus ART
Yangxin Jianpi Control Group:Antiretroviral Therapy
Sponsors
Institute of Basic Theory of Traditional Chinese Medicine China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 65 years regardless of gender; 2.Positive for HIV antibodies confirmed by Western Blot test; 3.Receiving antiretroviral therapy (ART) for more than 4 years with plasma HIV viral load maintained at <50 copies/ml for more than 3 years; 4.CD4+ T lymphocyte count below 350 cells/µL; 5.Traditional Chinese Medicine (TCM) diagnosis consistent with spleen and kidney yang deficiency syndrome or Spleen-Qi deficiency syndrome or Heart–Spleen deficiency syndrome ; 6.Willing to participate in this study and having signed the informed consent form.
Exclusion criteria
Exclusion criteria: Participants who meet the inclusion criteria but have any of the following conditions will be excluded: 1.Uncontrolled severe opportunistic infections before enrollment; 2.Patients who have participated in other drug clinical trials within one month before enrollment or are currently participating in such trials; 3.Participants who have received immunomodulatory therapy within one month before enrollment; 4.Participants who have used antibiotics (except sulfonamides) or probiotics within four weeks before stool sample collection; 5.Patients with gastrointestinal diseases; 6.Patients who have undergone gastrointestinal surgery; 7.Patients with significant dietary differences compared to other study participants or irregular eating habits; 8.White blood cell count (WBC) < 2×10^9/L neutrophil count (N) < 1.0×10^9/L hemoglobin (Hb) < 90 g/L platelet count (PLT) < 75×10^9/L or abnormal liver or kidney function (abnormal liver function is defined as AST or ALT or T-BIL = 2 times the upper limit of the reference range; abnormal kidney function is defined as creatinine clearance rate below the normal value); 9.Pregnant or breastfeeding women or women planning to become pregnant; 10.Patients with other severe comorbidities (such as cancer cirrhosis cardiovascular or cerebrovascular diseases etc.); 11.Patients with intellectual or language barriers who cannot fully understand the content of the study or provide adequate cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological Indicators;Inflammatory Indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| World Health Organization Quality of Life (WHOQOL) Scale;Clinical Symptoms; | — |
Countries
China
Contacts
Public ContactLiu Ying
Institute of Basic Theory of Traditional Chinese Medicine China Academy of Chinese Medical Sciences
Outcome results
None listed