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

ConditionsHuman Papillomavirus (HPV) InfectionCervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age25-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cnidium Monnieri Detoxification Formula

    Drug

    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, decocted into 300ml by a medicine decocter, packed in 2 vacuum bags, taken orally after meals, twice a day, one bag each time. Do not stop taking decoction during menstruation. 1 month is a course of treatment, at least 3 courses of treatment, no more than 6 courses of treatment. 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.

Treatment groups

79 Participants
are divided into 1 treatment group
Group A: Treatment (Cnidium Monnieri Detoxification Formula)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Baseline HPV clearance at 6 months after treatment

HPV clearance rate at 6 months after treatment

Time frame
6 months

Secondary outcomes

1

Baseline HPV clearance at 12 months after treatment

HPV clearance rate at 12 months after treatment

Time frame
12 months
2

Safety

Proportion of adverse events within 6 months of treatment

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: