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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
negative rate
Secondary Outcome
Adverse Events
Condition
Cervical Intraepithelial Neoplasia
Intervention
Composite Gel Containing Black Raspberry
Study Arms / Comparison Groups
Composite Gel Containing Black Raspberry
Description: Drug:Composite Gel Containing Black Raspberry 3,000mg Dosage and duration: 1 preparation every other day for 3 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
78
Start Date
December 2018
Completion Date
December 2019
Primary Completion Date
August 2019
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.
Gender
Female
Ages
20 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
, 022-23340123, [email protected]
Administrative Informations
NCT ID
NCT03745846
Organization ID
CIN-HPV-001
Responsible Party
Sponsor
Study Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study Sponsor
, ,
Verification Date
November 2018