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A prospective, randomized, double-blind, multi-center clinical study of Honghefu Jie liquid in the treatment of cervical high-risk HPV infection

A prospective, randomized, double-blind, multi-center clinical study of Honghefu Jie liquid in the treatment of cervical high-risk HPV infection

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074173
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

Cervical HPV Infection

Interventions

Experimental Group:Honghefu Jie lotion combined with Xinfuning
Control group:Honghefu Jie lotion placebo combined with Xinfuning

Sponsors

Changhai Hospital, Shanghai, China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) aged 21-65 years, non-pregnant, non-lactating, and having a history of sexual life; 2) diagnosed as uterine by any of the methods of HC2 test, HPV genotyping surveillance, or PCR Positive cervical high-risk human papillomavirus infection; 3) downpour type with dampness and heat; 4) no recent fertility requirements; 5) Thinprep cytology test (TCT) : NILM, inflammatory changes; 6) patients who voluntarily participated in the clinical trial and actively cooperated with follow-up and signed informed consent

Exclusion criteria

Exclusion criteria: 1) Thinprep cytologic test (TCT) for high-grade squamous intraepithelial lesions and invasive carcinoma;Patients with high-grade CIN II and above lesions by histopathology; 2) use of other HPV drugs or immunosuppressive drugs in the three months before enrollment; 3) pregnant and lactating women; 4) combined with mental disorders, or with important organ diseases or metabolic diseases; 5) combined with infectious diseases, such as tuberculosis, venereal diseases; 6) those with bad habits or recent exposure to toxic substances, such as drugs and X-rays; 7) are receiving additional clinical trial investigators.

Design outcomes

Primary

MeasureTime frame
Cervical HPV testing;

Secondary

MeasureTime frame
Cervical liquid-based cytology;

Countries

China

Contacts

Public ContactYu Chaoqin

Changhai Hospital, Shanghai, China

chqyu81@163.com+86 138 1839 0984

Outcome results

None listed

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