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Not yet recruiting NCT06705322

Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.

Phase II Interventional Human Papillomavirus (HPV) Infection Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cnidium Monnieri Detoxification Formula.
Who it may be relevant to
Registry conditions: Human Papillomavirus (HPV) Infection, Cervical Cancer. Basic parameters: 25 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II, Multicenter Study on the Clinical Effectiveness of Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.

Overview

The purpose of this study is to evaluate the clinical efficacy and safety of Cnidium Monnieri Detoxification Formula in clearing HPV infection, improving clinical symptoms and quality of life in female patients with persistent cervical high-risk HPV infection.

Detailed description

Persistent infection with high-risk HPV is a major cause of cervical cancer and has negative psychosocial effects on women's health-related quality of life (QOL). This prospective, single-arm, multicenter study is to evaluate the clinical efficacy and safety of Cnidium Monnieri Detoxification Formula in clearing HPV infection, improving clinical symptoms and quality of life in female patients with persistent cervical high-risk HPV infection.

Interventions

  • Drug Cnidium Monnieri Detoxification Formula
    Drug composition of Cnidium Monnieri Detoxification Formula: snake seed 9g, Tuckaia 30g, Matrine 9g, snake berry 30g, white Ying 30g. Based on the Cnidium Monnieri Detoxification Formula, the other symptoms were treated with syndrome differentiation and flavor. The traditional Chinese medicine decoction is provided by the Pharmacy of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, with 1 dose per day, deco

Primary outcome measures

  • Baseline HPV clearance at 6 months after treatment [Time frame: 6 months]
Secondary outcome measures (2)
  • Baseline HPV clearance at 12 months after treatment [Time frame: 12 months]
  • Safety [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 25 years to ≤ 75 years，with sexual life history
  • Meet the diagnostic criteria for high-risk human papillomavirus (HR-HPV) persistent infection
  • After surgery or physical therapy for high-grade squamous intraepithelial lesions (HSIL) of the cervix or high-grade squamous intraepithelial lesions (VaINIII) of the vagina, or radical surgery for cervical/vaginal cancer or radical chemoradiotherapy, the examination remained positive for HR-HPV ≥6 months after the end of treatment, with the same type or multiple types as before treatment, and no progression or recurrence of the disease.
  • No local or systemic therapy has been administered to patients in the last 3 months
  • Patients were informed of the study protocol, agreed to cooperate with the treatment, and signed informed consent.

Exclusion criteria

  • Only low-risk HPV infection
  • Colposcopy for high-grade intraepithelial lesions or cancer of the cervix, vagina, vulva, who have not received or are receiving treatment
  • Immunocompromised or immunosuppressant
  • Pregnant and lactating women
  • Patients with other malignant tumors not controlled, serious heart, lung, liver, renal insufficiency and coagulation dysfunction
  • People with communication or cognitive impairment
  • Patients have contraindications to oral administration of traditional Chinese medicine preparations
  • In the same period, other anti-HPV measures were used to treat, which affected the efficacy judgment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06705322 · zsfud-HPV-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗