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Research of The Effect of TCM Intervention on HIV Infected Persons

Research of The Effect of TCM Intervention on HIV Infected Persons

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003793
Enrollment
Unknown
Registered
2013-09-13
Start date
2013-10-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

HIV infection

Interventions

Group A:according to HIV infected for determining TCM constitution and TCM syndrome differentiation therapy, (1) The constitution of Qi deficiency, the medicine: Yiaikang capsules, each 5, 3 times dai
(2) The constitution of Qi deficiency and damp heat, the medicine: Tangcao tablets, each 8, 3 times daily, o
Group B:Chooses the corresponding with Group A Traditional Chinese medicine simulate agent. Experiment course: 12 months.

Sponsors

The First Affiliated Hospital of Henan College of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Meeting the “AIDS and HIV diagnostic criteria”(WS293-2008) diagnostic criteria for HIV infected; 2) According with the criteria of TCM constitution and Chinese medicine syndrome differentiation criteria; 3) CD4+ T lymphocyte levels 400-550/mm3; 4) HIV infection may be for 6 to 10 years (by diagnosed reports and epidemiological history to judge); 5) Aged between 18 and 65 years old, and no restriction on sex; 6) Signed informed consent, and voluntary to attend the trial.

Exclusion criteria

Exclusion criteria: 1) Who has been accepted norms HAART therapy (taking standard anti-viral treatment, well tolerated, and does not appear antiviral therapy treatment failure or termination); 2) Who has been accepted norms Traditional Chinese Medicine treatment: taking traditional Chinese medicine for the treatment of AIDS or decoction three months and above; 3) Participating in other treatment studies of patients; 4) Long-term survival or long-term non-progressors (HIV antibody positive more than seven years, CD4 + T cell count normal (greater than or equal 500/mm3) or no significant change, no clinical symptoms and antiviral drug use history. Refer to "AIDS virus and AIDS pathogenesis (third edition) "," HIV diagnosis and treatment, "" AIDS clinical research Integrative practical Guide "); 5) Pregnant or lactating women; 6) With severe heart, liver, kidney disease, hepatitis, tuberculosis patients and psychiatric patients include: severe organic heart disease, severe arrhythmias, abnormal liver function (AST, ALT increased more than 2 times), etc. 7) Other reasons of affect timely taking medications; 8) Allergies and allergic to this drug; 9) A history of alcoholism (daily drinking more than 150ml) or with alcohol dependence syndrome manifested; 10) Researchers believe that other reasons were not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Time of onset of AIDS;AIDS incidence rate;

Secondary

MeasureTime frame
Symptoms and signs of traditional Chinese Medicine;Opportunistic infection;Medication compliance;CD4+ T-lymphocyte subsets count;HIV viral load;Interleukin-2;interleukin-12;Tumor necrosis factor-a;Natural killer cell;B7-H1 expression of Peripheral blood myeloid dendritic cells;Expression of Toll-like receptor 4mRNA;CCR5(CC-chemokine receptor 5);CXCR4(CC-chemokine receptor 4);CD4+HLA-DR+;CD8+HLA-DR+ T lymphocytes;CD4+CD45RA+ T lymphocytes;CD4+CD45RO+ T lymphocytes;T cell receptor gene diversity analysis;CD8+ T-lymphocyte subsets count;Rate of CD4+/CD8+;WHOQOL-HIV- BREF;Report of outcome indicators in patients with measuring scale (PRO);

Countries

China

Contacts

Public ContactXU Liran

The First Affiliated Hospital of Henan College of TCM

xuliran666@sina.com+86 13633818030

Outcome results

None listed

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