Study for prevention and treatment of AIDS patients with incomplete immune function reconstruction (liver and kidney essence deficiency syndrome) by kidney tonifying and medullating

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002485

Enrollment

Unknown

Registered

2019-07-20

Start date

2019-08-01

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

Placebo control group:On the basis of the original HAART regimen,di wu yang gan capsule placebo was taken

Chinese medicine treatment group:On the basis of the original HAART regimen, di wu yang gan capsule was taken

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) HIV antibody was positive, confirmed by Western Blot; (2) HAART>=12 months; (3) CD4+T cell count increased by < 20% from baseline, or CD4+T cell count was still < 200 / mm3; (4) HIV RNA < 50 copies /ml for one year; (5) subjects aged between 18 and 65 years old, male or female; (6) TCM syndrome differentiation belongs to the deficiency certificate of liver and kidney essence; (7) voluntarily participate in this study, sign the informed consent, and follow up on time.

Exclusion criteria

Exclusion criteria: (1) before enrollment, severe opportunistic infections were not controlled (pneumocystis pneumoniae, meningitis, esophageal candida infection, lymphoma, toxoplasma encephalopathy, tuberculosis, etc.); (2) patients who are participating in clinical trials of other drugs within one month before enrollment; (3) those who received immunomodulator treatment within 1 month before enrollment; (4) WBC = 2 times the upper limit of reference value or creatinine detection >= 2 times the upper limit of reference value); (5) patients with pancreatitis and active gastric ulcer; (6) diseases of the active respiratory system, digestive system, circulatory system, blood system, neuroendocrine system and urogenital system of clinical significance; (7) patients with autoimmune diseases; (8) tumor patients requiring chemotherapy; (9) pregnant or lactating women and women of childbearing age who do not use safe contraception; (10) those with allergic conditions; (11) patients with intellectual or language barriers who cannot fully understand the test content or give good cooperation; (12) other circumstances considered unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
General project indicators;Safety index;Explore the mechanism of action and research indicators;Efficacy index;	—

Countries

China

Contacts

Public ContactJianzhong Liu

Hubei Provincial Hospital of Traditional Chinese Medicine

ljzwd@163.com+86 13307173928

Outcome results

None listed

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