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

• ClinicalTrials.gov Identifier: NCT03745846
• Recruitment Status: Unknown
• First Posted: November 19, 2018
• Last Update Posted: November 19, 2018
• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Information provided by (Responsible Party): Tianjin Medical University Cancer Institute and Hospital

Tracking Information

• First Submitted Date: November 13, 2018
• First Posted Date: November 19, 2018
• Last Update Posted Date: November 19, 2018
• Estimated Study Start Date: December 2018
• Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 15, 2018)

negative rate [ Time Frame: 3 months ]

the effective rate and clearance rate of HPV infection from baseline as compared to placebo

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 15, 2018)

• Adverse Events [ Time Frame: 3 months ]
  The Rate of Solicited Adverse Events and the Related Features
• recurrence rate [ Time Frame: 3 months ]
  The recurrence rate after HPV clearance was assessed

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: A Phase 2 Trial to Evaluate the Efficacy and the Safety of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Cervical Intraepithelial Neoplasia
• HPV

Intervention

• Biological: Composite Gel Containing Black Raspberry
  Composite Gel Containing Black Raspberry 3,000/preparation
• Biological: placebo
  Composite Gel Containing Black Raspberry-placebo

Study Arms

• Experimental: Composite Gel Containing Black Raspberry
  Drug:Composite Gel Containing Black Raspberry 3,000mg Dosage and duration: 1 preparation every other day for 3 months.
  Intervention: Biological: Composite Gel Containing Black Raspberry
• Placebo Comparator: 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.
  Intervention: Biological: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 15, 2018): 78
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03745846
• Other Study ID Numbers: CIN-HPV-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• Study Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tianjin Medical University Cancer Institute and Hospital
• Verification Date: November 2018