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Multicenter randomized double-blind placebo-controlled clinical trial of Kushen gel in the treatment of persistent cervical high-risk HPV infection

Multicenter randomized double-blind placebo-controlled clinical trial of Kushen gel in the treatment of persistent cervical high-risk HPV infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000214
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

persistent cervical high-risk HPV infection

Interventions

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)age: 18-65 years non-pregnancy non-lactation sexual life history; 2) Patients diagnosed with cervical high-risk HPV positive infection for 6 months or more by HC2 test HPV subtype testing and PCR (i. e. the reporting interval between two high-risk HPV types is at least 6 months); 3) No fertility requirements in the past 7 months; 4) Newberg's liquid-based cytological test (TCT)or LCT test: no intraepithelial lesions or malignant lesions or inflammatory changes or ASC-US or LSIL have undergone histopathological examination results of inflammation and LSIL; 5) Patients who voluntarily join the clinical trial and actively cooperate with the follow-up and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1)allergy to matshen gel and its components; 2)Colposcopic histopathological examination of HSIL AIS and above lesions; 3)Non-menopausal patients with menstrual disorders who can not be used in normal cycles; 4)Using other drugs or immunosuppressive drugs for HPV infection for 3 months prior to enrollment; 5)The acute inflammation of the reproductive tract needs to be treated (bacterial vaginosis vulvovaginal pseudogenosis trichomonas vaginitis acute cervicitis etc.; 6)Combined with mental diseases or accompanied by important organ diseases or metabolic diseases; 7)Have bad life habits or recent exposure to toxic substances such as drugs. 8)Use of topical vaginal drugs such as antimicrobial drugs and lactobacillus preparations within 7 days before enrollment;9) in process with other clinical trial .

Design outcomes

Primary

MeasureTime frame
he negative conversion rates of hr-HPV;

Secondary

MeasureTime frame
the negative conversion rates of hr-HPV subtypes;the negative conversion rates of hr-HPV subtypes;the negative conversion rates of hr-HPV;Alterations in vaginal microbiota 16S rRNA sequencing before and after treatment;

Countries

China

Contacts

Public ContactLong Sui

0bstetrics & Gynecology Hospitalof Fudan University

suilong@fudan.edu.cn021 33189900

Outcome results

None listed

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