Cervical Intraepithelial NeoplasiaPhase 2NCT03745846
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
A Phase 2 study testing Composite Gel Containing Black Raspberry in people with Cervical Intraepithelial Neoplasia and HPV, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, HPV
- What is being tested?
- Composite Gel Containing Black Raspberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia, HPV
- Being tested
- Composite Gel Containing Black Raspberry, placebo
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite Gel Containing Black RaspberryBiological
Composite Gel Containing Black Raspberry 3,000/preparation
placeboBiological
Composite Gel Containing Black Raspberry-placebo
| Study group | Role | What they receive |
|---|---|---|
| Composite Gel Containing Black Raspberry | Experimental | Drug:Composite Gel Containing Black Raspberry 3,000mg Dosage and duration: 1 preparation every other day for 3 months. Receives: Biological: Composite Gel Containing Black Raspberry |
| Composite Gel Containing Black Raspberry-placebo | Placebo comparator | Drug:Composite Gel Containing Black Raspberry-placebo 3,000mg Dosage and duration: 1 preparation every other day for 3 months. Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative rate
the effective rate and clearance rate of HPV infection from baseline as compared to placebo
Measured: 3 months
Secondary outcomes (2)
Adverse Events
The Rate of Solicited Adverse Events and the Related Features
Measured: 3 months
recurrence rate
The recurrence rate after HPV clearance was assessed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745846
- Sponsor's protocol ID
- CIN-HPV-001
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03745846
- Acronym / sponsor ID
- CIN-HPV-001
- Conditions
- Cervical Intraepithelial Neoplasia, HPV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite Gel Containing Black Raspberry | Experimental | Biological: Composite Gel Containing Black RaspberryDrug:Composite Gel Containing Black Raspberry 3,000mg Dosage and duration: 1 preparation every other day for 3 months. |
| Composite Gel Containing Black Raspberry-placebo | Placebo comparator | Biological: placeboDrug:Composite Gel Containing Black Raspberry-placebo 3,000mg Dosage and duration: 1 preparation every other day for 3 months. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Composite Gel Containing Black RaspberryComposite Gel Containing Black Raspberry 3,000/preparation | Biological | Composite Gel Containing Black Raspberry |
| placeboComposite Gel Containing Black Raspberry-placebo | Biological | Composite Gel Containing Black Raspberry-placebo |
Primary outcome
negative rate
Time frame: 3 months
the effective rate and clearance rate of HPV infection from baseline as compared to placebo
2 secondary outcomes
Adverse Events
Time frame: 3 months
recurrence rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Composite Gel Containing Black Raspberry in people with Cervical Intraepithelial Neoplasia and HPV, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wen xin Liu, MD、PHD (022-23340123 ext. 3120, wenxin1973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.