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A randomized controlled, double-blind, single-simulation trial for the method of invigorating the spleen, clearing heat and removing dampness in the treatment of high-risk HPV infection

A randomized controlled, double-blind, single-simulation trial for the method of invigorating the spleen, clearing heat and removing dampness in the treatment of high-risk HPV infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003689
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
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

HPV infection

Interventions

Experimental group:traditional Chinese medicine+Interferon
Control group:Traditional Chinese Medicine Simulator + Interferon

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Female, with a history of sexual life, aged 21 to 55 years; (2) Meet the medical diagnostic criteria for high-risk HPV infection; (3) Meet the TCM diagnostic criteria for spleen deficiency with damp-heat betting; (4) TCT detection is NILM, AS-CUS, LSIL or CIN I; (5) The pathology of colposcopy cervical biopsy is LSIL or CIN I and below; (6) Have not treated cervical-related diseases in the past 3 months; (7) Those who are willing to participate in this study and follow the experimental plan; (8) Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: (1) Women during pregnancy or lactation; (2) Patients with severe cardiovascular, liver, kidney, brain and other major organ diseases, hematopoietic system diseases, and immune system diseases; (3) People with history of mental illness and impaired consciousness; (4) Those with a history of gynecological malignant tumors and reproductive tract surgery; (5) Those who have recently taken drugs that affect the immune function of the body or corticosteroids; (6) Those who have recently used systemic or topical antiviral drugs, and those who have systemic lupus erythematosus, AIDS, and other diseases that lead to low immune function; (7) Acute genital tract inflammation, pelvic inflammation and other gynecological inflammation; (8) Those who are accompanied by other virus infections; (9) Those who are allergic to the drugs in this study; (10) Those who accept other clinical trials during the study period.

Design outcomes

Primary

MeasureTime frame
TCT (Thinprep cytologic test);Liver and kidney function;Immunohistochemistry;Immune factor;ECG;Human papilloma virus;Urine HCG;Urine routine;Blood routine;—

Countries

China

Contacts

Public ContactHuicong Liu

Longhua Hospital Shanghai University of Traditional Chinese Medicine

903180049@qq.com+86 18817943881

Outcome results

None listed

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