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

NCT ID: NCT06705322

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-03-27

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.

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.

Conditions

Human Papillomavirus (HPV) Infection; Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (Cnidium Monnieri Detoxification Formula)

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.

Group Type: EXPERIMENTAL

Cnidium Monnieri Detoxification Formula

Intervention Type: 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.

Interventions

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, 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Libing Xiang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tingyan Shi

Role: CONTACT

shi.tingyan@zs-hospital.sh.cn

86-21-64041990 ext. 2801

Other Identifiers

zsfud-HPV-001

Identifier Type: -

Identifier Source: org_study_id