NCT06661083

Brief Summary

The purpose of the study is to evaluate the effect of the administration of natural molecules in the treatment of HPV infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

October 23, 2024

Last Update Submit

March 17, 2025

Conditions

HPV (Human Papillomavirus)-associated

Outcome Measures

Primary Outcomes (1)

  • HPV DNA test negativity

    Percentage

    6 months of treatment

Study Arms (1)

Patients with HPV infection

EXPERIMENTAL
Dietary Supplement: EGCG, FA, HA, B12

Interventions

EGCG, FA, HA, B12DIETARY_SUPPLEMENT

EGCG + FA + HA + B12 (1 cps /die)

Patients with HPV infection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HPV DNA test positivity
  • over 18 years

You may not qualify if:

  • pregnancy
  • breastfeeding
  • assumption of other products containing EGCG or green tea
  • primary immunodepression or pharmacological induced one

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agunco

Rome, Italy

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

epigallocatechin gallateVitamin 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)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 28, 2024

Study Start

August 1, 2024

Primary Completion

February 28, 2025

Study Completion

March 7, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

IT(1)