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Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

Primary Purpose

Papilloma, Cervix Lesion

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid
Sponsored by
Lo.Li.Pharma s.r.l
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papilloma

Eligibility Criteria

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

Inclusion Criteria: HPV infections Occurrence of low-grade cervical lesions Exclusion Criteria: Diagnosis of malignancy or severe cervical lesions Concurrent uterine pathologies Pregnancy or intended to seek pregnancy in the next three months Cancer

Sites / Locations

  • Clinica Alma Res

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Co-treatment with EGCG, FA, B12, and HA

Control

Arm Description

One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks.

Untreated women.

Outcomes

Primary Outcome Measures

Regression of cervical lesions
The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
December 21, 2022
Sponsor
Lo.Li.Pharma s.r.l
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1. Study Identification

Unique Protocol Identification Number
NCT05625308
Brief Title
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
Official Title
Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
December 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Co-treatment with EGCG, FA, B12, and HA
Arm Type
Experimental
Arm Description
One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Untreated women.
Intervention Type
Dietary Supplement
Intervention Name(s)
Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid
Intervention Description
One tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid.
Primary Outcome Measure Information:
Title
Regression of cervical lesions
Description
The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HPV infections Occurrence of low-grade cervical lesions Exclusion Criteria: Diagnosis of malignancy or severe cervical lesions Concurrent uterine pathologies Pregnancy or intended to seek pregnancy in the next three months Cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Aragona, MD
Organizational Affiliation
Clinica Alma Res
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Alma Res
City
Roma
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

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