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

NCT06705322 | Not Yet Recruiting Phase 2

• 1 other identifier: zsfud-HPV-001
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Human Papillomavirus (HPV) Infection; Cervical Cancer

Keywords

Human papillomavirus infection; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• Baseline HPV clearance at 6 months after treatment

  HPV clearance rate at 6 months after treatment

  6 months

Secondary Outcomes (2)

• Baseline HPV clearance at 12 months after treatment

  12 months

• Safety

  6 months

Study Arms (1)

Treatment (Cnidium Monnieri Detoxification Formula)

EXPERIMENTAL

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.

Drug: Cnidium Monnieri Detoxification Formula

Interventions

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 (Cnidium Monnieri Detoxification Formula)

Eligibility Criteria

• Age: 25 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Papillomavirus Infections; Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Central Study Contacts

Tingyan Shi

CONTACT

86-21-64041990; shi.tingyan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): March 27, 2027
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share