NCT06705322Not yet recruitingPhase 2
Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.
A Phase II, Multicenter Study on the Clinical Effectiveness of Cnidium Monnieri Detoxification Formula for Persistent High-risk Human Papillomavirus Infection of Cervix.
Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (estimated)
- First submitted
- 23 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 27 Mar 2027
- Lead sponsor
- Fudan University
- Diseases
- Cervical cancer
- NCT number
- NCT06705322
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 79
- From 1 Dec 2024 to the primary completion date, 27 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Colposcopy for high-grade intraepithelial lesions or cancer of the cervix, vagina, vulva, who have not received or are receiving treatment
Other illness
- Only low-risk HPV infection
- Patients with other malignant tumors not controlled, serious heart, lung, liver, renal insufficiency and coagulation dysfunction
- People with communication or cognitive impairment
Other
- Immunocompromised or immunosuppressant
- Pregnant and lactating women
- 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
Who the study is looking for
- 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.
Age in the registry: 25 years to 75 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.