Clinical Trial of Traditional Chinese Medicine for the Early Phase of Asymptomatic HIV infection

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000957

Enrollment

Unknown

Registered

2010-07-28

Start date

2009-04-10

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

Asymptomatic HIV infection

Interventions

Group A:1. no type to distinguish or Qi-deficiency type: oral Yi Aikang capsule: 5 grains each time, 3 times daily

2. Yin deficient type: oral Aining pellet 1 bag each time, 3 times daily

3. hot and damp type: oral Tang Caopian 8 pieces each time, 3 times daily

4. blood stasis type: oral Ai Qikang capsule, 3 grains each time, 3 times daily

5. phlegm and blood stasis type, oral The Jinlong capsule, 4 grains, three times daily. Total course: 18 months

Group B:Chooses the corresponding wiht Group A Traditional Chinese medicine analog formulations. Experiment course is18 months

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for asymptomatic HIV infection; 2. accord with the diagnostic criteria by Traditional Chinese Medicine Syndrome; 3. CD4 + T cell levels in the 300-450mm3; 4. Aged between 18 and 60 years old, and no restriction on sex; 5. Signed informed consent, and voluntary to attend the trial.

Exclusion criteria

Exclusion criteria: 1. On acute phase and AIDS; 2. Accepted standard medical treatment by HAART or TCM; 3. participating in clinical trials of drugs or termination under the age in last 3 months; 4. Pregnant or lactating women; 5. With severe heart, liver (ALT more than 2 times normal), kidney disease (BUN, CR exception), tuberculosis patients and the mentally ill; 6. Other reasons of affect timely taking medications; 7. Allergies and allergic to this drug; 8. History of heavy drinking (daily drinking 250ml or more); 9. Researchers believe that other reasons were not suitable for clinical trials.

Design outcomes

Primary

Measure	Time frame
the time the symptomless HIV infected patients taken bad;AIDS incidence rate;	—

Secondary

Measure	Time frame
CD4+/ CD8+ratio;CD4+CD45RO+;TNF-a;IL-2;CD4+count;CD4+CD45RA+;HIV viral load capacity;IL-12;CD8+count;Quality of Life Scale;Report of outcome indicators in patients with measurement;NK cell;	—

Countries

China

Contacts

Public ContactLiran Xu

xuliran666@sina.com+86 371 66288898

Outcome results

None listed

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