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

NCT ID: NCT05625308

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Papilloma Cervix Lesion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

Intervention Type DIETARY_SUPPLEMENT

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.

Control

Untreated women.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cesare Aragona, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Alma Res

Locations

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Clinica Alma Res

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HPV-NAT-COM

Identifier Type: -

Identifier Source: org_study_id