Clinical trial · Interventional
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.
NCT06705322CI-TRIAL-00082989not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Human Papillomavirus (HPV) Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cnidium Monnieri Detoxification Formula | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Cnidium Monnieri Detoxification Formula)
- description
- Take Cnidium Monnieri Detoxification Formula orally for at least 3 months. Baseline HPV clearance, improvement in clinical symptoms and quality of life, and drug safety were assessed at 3 months, 6 months, and 12 months after initiation of treatment.
- interventionNames
- Drug: Cnidium Monnieri Detoxification Formula
Primary outcomes (1)
- measure
- Baseline HPV clearance at 6 months after treatment
- timeFrame
- 6 months
- description
- HPV clearance rate at 6 months after treatment
Secondary outcomes (2)
- measure
- Baseline HPV clearance at 12 months after treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.