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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

Primary Purpose

Cervical Intraepithelial Neoplasia, HPV

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Composite Gel Containing Black Raspberry

placebo

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Composite Gel Containing Black Raspberry

Composite Gel Containing Black Raspberry-placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

negative rate

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

Secondary Outcome Measures

Adverse Events

The Rate of Solicited Adverse Events and the Related Features

recurrence rate

The recurrence rate after HPV clearance was assessed

Full Information

NCT ID

NCT03745846

First Posted

November 13, 2018

Last Updated

November 15, 2018

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03745846

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2018 (Anticipated)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Intraepithelial Neoplasia, HPV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Composite Gel Containing Black Raspberry

Arm Type

Experimental

Arm Description

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

Arm Title

Composite Gel Containing Black Raspberry-placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Composite Gel Containing Black Raspberry

Intervention Description

Composite Gel Containing Black Raspberry 3,000/preparation

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

Composite Gel Containing Black Raspberry-placebo

Primary Outcome Measure Information:

Title

negative rate

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

The Rate of Solicited Adverse Events and the Related Features

Time Frame

3 months

Title

recurrence rate

Description

The recurrence rate after HPV clearance was assessed

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wen xin Liu, MD、PHD

Phone

022-23340123

Ext

3120

wenxin1973@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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