NCT06285357

Brief Summary

The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Feb 2024Aug 2026

Study Start

First participant enrolled

February 19, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

November 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

February 22, 2024

Last Update Submit

November 19, 2025

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (1)

  • HPV DNA test negativity

    Percentage

    8 months of treatment

Study Arms (2)

control

NO INTERVENTION

treatment

EXPERIMENTAL
Dietary Supplement: EGCG + folic acid + B12

Interventions

EGCG + folic acid + B12DIETARY_SUPPLEMENT

EGCG + folic acid + B12

treatment

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HR-HPV DNA test positivity

You may not qualify if:

  • No HSIL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria di Modena

Modena, Modena, 41124, Italy

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

epigallocatechin gallateFolic AcidVitamin B 12

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic Compounds

Central Study Contacts

Giovanni Grandi

CONTACT

+390594222830giovanni.grandi@unimore.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

February 19, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

November 20, 2025

Record last verified: 2025-03

Locations

IT(1)