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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03745846
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date November 19, 2018
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Intraepithelial Neoplasia
  • HPV
Intervention  ICMJE
  • Biological: Composite Gel Containing Black Raspberry
    Composite Gel Containing Black Raspberry 3,000/preparation
  • Biological: placebo
    Composite Gel Containing Black Raspberry-placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2018)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: wen xin Liu, MD、PHD 022-23340123 ext 3120 wenxin1973@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03745846
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP