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The Validation Study on TCM Diagnosis and Treatment Plan of Immune Reconstitution Insufficiency of HIV/AIDS (Syndrome of qi deficiency and blood stasis, Spleen and kidney deficiency syndrome)

The Validation Study on TCM Diagnosis and Treatment Plan of Immune Reconstitution Insufficiency of HIV/AIDS (Syndrome of qi deficiency and blood stasis, Spleen and kidney deficiency syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009431
Enrollment
Unknown
Registered
2016-10-15
Start date
2016-12-01
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/AIDS

Interventions

Test group of Syndrome of qi deficiency and blood stasis:Shenling Fuzheng prescription of traditional Chinese medicines
Control group of Syndrome of qi deficiency and blood stasis:Simulation agent of Shenling Fuzheng prescription
Test group of Spleen and kidney deficiency syndrome:Jian Ai Kang prescription of traditional Chinese medicines
Control group of Spleen and kidney deficiency syndrome:Simulation agent of Jian Ai Kang prescription

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. HIV antibody positive, confirmed by Blot Western confirmatory test; 2. HAART treatment is greater than or equal to 12 months; 3. CD4+T cell counts compared to the baseline growth of < 20% or CD4+T < 200 /mm3 cell count; 4. HIV RNA is less than 50 copies /ml over 1 years; 5. Male or female patient aged 18 to 65 years old; 6. qi deficiency and blood stasis syndrome,or Spleen and kidney deficiency syndrome; 7. Voluntarily participated in this study, signed informed consent, can be followed up on time.

Exclusion criteria

Exclusion criteria: 1. Serious opportunistic infection has not been control (pulmonary carinii pneumonia, meningitis, and esophageal candidiasis infection, lymphoma, Toxoplasma encephalopathy, tuberculosis, etc.); 2. Patients who are taking part in clinical trials of other drugs, or the end of the trial did not exceed 1 months; 3. Immunomodulator treatment within 1 months of receiving; 4. WBC<2×10^9/L N<1.0×10^9/L Hb<90g/L PLT<75×10^9/L,Liver or Renal function sufficiency(AST, ALT, T-BIL more than 2 times the upper limit of the reference value or the reference value of serum creatinine value is more than 2 times the upper limit); 5. Pancreatitis, active gastric ulcer; 6. Clinical significance of active respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, urinary and reproductive system diseases; 7. People with autoimmune diseases; 8. Cancer patients requiring chemotherapy; 9. Women of childbearing age who were pregnant or nursing women and those who did not use safe contraception; 10. Allergic constitution; 11. Mental or language barriers exist, can not fully understand the content of the test or to give good cooperation in patients; 12. Other conditions that the researchers considered unsuitable for the trial.

Design outcomes

Primary

MeasureTime frame
Symptoms and signs of traditional Chinese Medicine;T lymphocyte subsets count;HIV viral load;

Secondary

MeasureTime frame
Quality of life;

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