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

NCT03745846 | Unknown Phase 2 DMC

• 1 other identifier: CIN-HPV-001
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cervical Intraepithelial Neoplasia; HPV

Outcome Measures

Primary Outcomes (1)

• negative rate

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

  3 months

Secondary Outcomes (2)

• Adverse Events

  3 months

• recurrence rate

  3 months

Study Arms (2)

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.

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.

Biological: placebo

Interventions

Composite Gel Containing Black Raspberry BIOLOGICAL

Composite Gel Containing Black Raspberry 3,000/preparation

Composite Gel Containing Black Raspberry

placebo BIOLOGICAL

Composite Gel Containing Black Raspberry-placebo

Composite Gel Containing Black Raspberry-placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

wen xin Liu, MD、PHD

CONTACT

022-23340123; wenxin1973@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 19, 2018
• Study Start: December 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 19, 2018

Record last verified: 2018-11