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Clinical study of Qushi Jiedu Granule on promoting immune function reconstruction in HIV/AIDS patients after ART

Based on Qushijiedu method to improve the function of digestive tract mucosa in HIV/AIDS patients to intervene the mechanism of PD-1 receptor mediated immunosuppressionClinical study of Qushi Jiedu Granule on promoting immune function reconstruction in HIV/AIDS patients after ART

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000390
Enrollment
Unknown
Registered
2025-02-24
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

AIDS Immunological Non-responder

Interventions

treatment group:ART + Qushi Jiedu Granules
control group:ART

Sponsors

Research on Basic Theory of Traditional Chinese Medicine in China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 ) Age 18-65 years old men and women are not limited ; 2 ) HIV antibody positive confirmed by Western Blot confirmation test ; 3 ) The duration of ART treatment was more than 4 years and the plasma HIV load < 50copies / ml was more than 3 years ; 4 ) CD4 + T lymphocyte count less than 350 cells / ul ; 5 ) TCM syndrome differentiation in line with damp-heat syndrome ; 6 ) Voluntary to participate in this study signed informed consent.

Exclusion criteria

Exclusion criteria: 1)severe opportunistic infections were not controlled before enrollment ; 2)Patients within 1 month before enrollment or participating in clinical trials of other drugs ; 3)Patients who received immunomodulator therapy within 1 month before enrollment ; 4)WBC < 2 × 109 / L N < 1.0 × 109 / L Hb < 90g / L PLT < 75 × 109 / L abnormal liver and kidney function ( abnormal liver function refers to AST or ALT or T-BIL = 2 times the upper limit of reference value abnormal renal function refers to creatinine clearance rate lower than normal ). 5)pregnant or lactating women or women preparing for pregnancy ; 6)combined with other serious diseases ( such as tumors cirrhosis cardiovascular and cerebrovascular diseases etc. ) ; 7)Patients with intellectual or language barriers who could not fully understand the content of the trial or give good cooperation.

Design outcomes

Primary

MeasureTime frame
immunologic index;

Secondary

MeasureTime frame
clinical symptoms;inflammation-related indicators;WHOQOL-HIV BREF;

Countries

China

Contacts

Public Contactliuying

Institute of Basic Theory of Chinese Medicine China Academy of Chinese Medical Sciences

liuying0516@163.com+86 130 2198 5109

Outcome results

None listed

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