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Clinical intervention study of Chinese and Western medicine in people with AIDS immunocompromised state

Clinical intervention study of Chinese and Western medicine in people with AIDS immunocompromised state

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005974
Enrollment
Unknown
Registered
2022-05-04
Start date
2022-05-31
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS

Interventions

Liver and kidney essence deficiency treatment group:HAART treatment + Chinese medicine "Diwu Yanggan Capsule" treatment
control group:The usual care group received HAART only
Lung spleen deficiency treatment group:HAART treatment + Chinese medicine "Fuzheng Kangai Granules" treatment

Sponsors

Hubei Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? HIV antibody positive, confirmed by Western Blot confirmation test; ? Voluntary acceptance of HAART; ? CD4+ cell count <350 cells/µL; ? The subjects are between 18-65 years old, male or female; ? TCM syndrome differentiation is in line with lung-spleen deficiency syndrome or liver-kidney essence deficiency syndrome; ? Voluntarily participate in this study, sign the informed consent form, and follow up on time.

Exclusion criteria

Exclusion criteria: ? Those with uncontrolled serious opportunistic infections (Pneumocystis pneumonia, meningitis, esophageal Candida infection, lymphoma, Toxoplasma encephalopathy, tuberculosis, etc.) before enrollment; ? Patients who are participating in clinical trials of other drugs within 1 month before enrollment; ? Those who received immunomodulatory therapy within 1 month before enrollment; ? White blood cell (WBC) count <2.0×109/L, or neutrophil (N) count <1.0×109/L, or hemoglobin (Hb) amount <90g/L, or platelet (PLT) count <75×109 /L, or liver or renal insufficiency (aspartate aminotransferase (AST), aspartate aminotransferase (ALT), total bilirubin (TBIL) = 2 times the upper limit of the reference value or urea nitrogen (BUN) ), serum creatinine (Scr) detection value = 1.2 times the upper limit of the reference value); ? Patients with pancreatitis and active gastric ulcer; ? Patients with clinically significant active diseases of the respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, and urogenital system; ? Those who suffer from autoimmune diseases; ? Tumor patients who need chemotherapy; ? Pregnant or breastfeeding women and women of childbearing age who do not use safe contraception; ? allergic constitution; ? Patients with intellectual or language barriers who cannot fully understand the test content or give good cooperation; ? Other circumstances that the investigator considers inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
T cell subsets;TCM syndrome score;

Secondary

MeasureTime frame
Comorbidity rate;Opportunistic infection incidence and mortality;HIV/AIDS PRO Scale;HIV viral load;inflammatory markers;

Countries

China

Contacts

Public ContactLiu Jianzhong

Hubei Provincial Hospital of Traditional Chinese Medicine

ljzwd@163.com13307173928

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026