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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03745846
Recruitment Status : Unknown
Verified November 2018 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  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

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

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia HPV Biological: Composite Gel Containing Black Raspberry Biological: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: Composite Gel Containing Black Raspberry
Composite Gel Containing Black Raspberry 3,000/preparation

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.
Biological: placebo
Composite Gel Containing Black Raspberry-placebo




Primary Outcome Measures :
  1. negative rate [ Time Frame: 3 months ]
    the effective rate and clearance rate of HPV infection from baseline as compared to placebo


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 months ]
    The Rate of Solicited Adverse Events and the Related Features

  2. recurrence rate [ Time Frame: 3 months ]
    The recurrence rate after HPV clearance was assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745846


Contacts
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Contact: wen xin Liu, MD、PHD 022-23340123 ext 3120 wenxin1973@163.com

Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03745846    
Other Study ID Numbers: CIN-HPV-001
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type