A Efficacy and Safety Study of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization

NCT ID: NCT03745846

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2019-12-31

Brief Summary

To evaluate the efficacy and safety of composite gel containing black raspberry extract in removing HPV From patients With cervical intraepithelial neoplasia(CIN) after cervical conization

Detailed Description

A large number of basic research and animal experiments have confirmed that black raspberry and its active ingredients are used for chemo-prevention of tumors. In recent years, it has been reported that black raspberry extract can effectively inhibit the proliferation of human oral cancer cells and colorectal cancer cells and promote its apoptosis. At the same time, studies have found that chemically modified lactoglobulin exhibits highly potent antiviral activity against human papillomavirus (HPV) infection, including HPV6, HPV16 and HPV18, and can be used as an effective and safe antiviral drug for treatment and Prevent HPV infection. This study attempts to apply black raspberry and lactoglobulin to remove HPV virus and prevent cervical cancer, in order to make breakthroughs in the prevention and control of cervical cancer.

Conditions

Cervical Intraepithelial Neoplasia; HPV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Composite Gel Containing Black Raspberry

Drug:Composite Gel Containing Black Raspberry 3,000mg Dosage and duration: 1 preparation every other day for 3 months.

Group Type: EXPERIMENTAL

Composite Gel Containing Black Raspberry

Intervention Type: BIOLOGICAL

Composite Gel Containing Black Raspberry 3,000/preparation

Composite Gel Containing Black Raspberry-placebo

Drug:Composite Gel Containing Black Raspberry-placebo 3,000mg Dosage and duration: 1 preparation every other day for 3 months.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

Composite Gel Containing Black Raspberry-placebo

Interventions

Composite Gel Containing Black Raspberry

Composite Gel Containing Black Raspberry 3,000/preparation

Intervention Type: BIOLOGICAL

placebo

Composite Gel Containing Black Raspberry-placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects were able and willing to sign informed consent.
• Patients with CIN who underwent cervical conization were at high risk of persistent HPV infection.
• Age must be between 20-55 years old.
• Subjects should begin receiving protocol studies at least two months after cervical conization.
• Patients must be readily available for study and follow-up.
• Patients should not participate in other clinical trials at the same time and agree not to participate in other interventional clinical trials during the protocol study. Except for questionnaires or observational studies.
• Patients should have appropriate nutritional status: body mass index BMI ≥ 18 kg / m2, body weight > 40 kg, serum albumin ≥ 3 g / dL.

Exclusion Criteria

Anyone who meets any of the following criteria is not allowed to participate in this test:

• Pregnant women, pregnant and lactating women.
• Patients who participated in other clinical trials in the past 3 months.
• It has a serious primary disease such as cardiovascular and cerebrovascular, hematopoietic system and liver and kidney, or patients with mental illness.
• Allergic patients.
• People with epidemics such as AIDS.
• Suffering from uncontrolled complications, including but not limited to: persistent or active infection; clinically significant healing or non-healing wounds; symptomatic congestive heart failure; unstable angina; clinically significant arrhythmia; A disease that affects research compliance, such as an infectious disease or a mental illness/social condition.
• Active, uncontrolled bacterial, viral or fungal infections and require systemic treatment.
• The patient has a history of other malignancies or is suffering from malignant tumors and autoimmune diseases.
• Have any active disease that may increase the risk of a program study or impair a patient's ability to receive protocol research.
• Patients who plan to stay on vacation for 14 days or more during the study period.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

wen xin Liu, MD、PHD

Role: CONTACT

wenxin1973@163.com

022-23340123 ext. 3120

Other Identifiers

CIN-HPV-001

Identifier Type: -

Identifier Source: org_study_id