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A randomized, double-blind, placebo-controlled trial was carried out to study the effect of Ganoderma lucidum spores on immune response and metabolomics in HIV/AIDS patients with poor immune reconstitution

A randomized, double-blind, placebo-controlled trial was carried out to study the effect of Ganoderma lucidum spores on immune response and metabolomics in HIV/AIDS patients with poor immune reconstitution

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076429
Enrollment
Unknown
Registered
2023-10-08
Start date
2023-10-20
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

incomplete immune Reconstruction of AIDS

Interventions

experimental group:ART+RGLSP
Control Group:ART+placebo

Sponsors

Xixi Hospital of Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-70, Gender Unlimited; 2.HIV infection is diagnosed in the laboratory and the diagnostic criteria follow the Chinese guidelines for the diagnosis and treatment of AIDS (2021 version) . 3.After ART, the viral load was below the low limit of detection ( 24 months, CD4 + T cell count was > 350/mL; 4. Good compliance, voluntary participation in the study, signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Recent heavy drinking (>3 times per week, >4 times per day) 2.Patients taking Sulfamethoxazole tablets 3.Serious Opportunistic infection, such as Pneumocystis pneumonia, tuberculosis, non-tuberculous mycobacterial infection, Cytomegalovirus infection, etc. 4.Complicated with severe heart, cerebrovascular disease, liver and kidney insufficiency, autoimmune disease, tumor and mental illness. 5.There are intelligence and language communication barriers, can not understand the content of the experiment and to cooperate with the experiment; 6.A woman who is pregnant, nursing, or planning a pregnancy. 7.People taking immunomodulators 8. Poor compliance, can not be required to take regular medication.

Design outcomes

Primary

MeasureTime frame
CD4+T cell count;CD8+T cell count;NK cell count;CD4+T/CD8+T;

Secondary

MeasureTime frame
Metabolomics;

Countries

China

Contacts

Public ContactJianhua Yu

Xixi Hospital of Hangzhou

yujhmc@126.com+86 135 8807 8478

Outcome results

None listed

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