NCT06314113

Brief Summary

The study aims to evaluate the effectiveness of the synergy of oral Epigallocatechin Gallate as a treatment for Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) infection.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

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 Start

First participant enrolled

March 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 10, 2024

Last Update Submit

March 10, 2024

Conditions

Low-Grade Intraepithelial Neoplasia of Cervix

Keywords

Human Papilloma Virus (HPV)Low-Grade Intraepithelial Neoplasia of CervixEpigallocatechin Gallate

Outcome Measures

Primary Outcomes (1)

  • Persistence

    Persistence of Low-grade Cervical Lesions (L-SIL), evaluated by pap smear

    After 6, 12, 18, and 24 months from the recruitment

Study Arms (1)

Low-grade Cervical Lesions (L-SIL)

Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

Dietary Supplement: Epigallocatechin Gallate

Interventions

Epigallocatechin GallateDIETARY_SUPPLEMENT

Oral treatment with Epigallocatechin Gallate 200 mg per day

Low-grade Cervical Lesions (L-SIL)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

You may qualify if:

  • Women affected by Low-grade Cervical Lesions (L-SIL) associated with Human Papilloma Virus (HPV) Infection

You may not qualify if:

  • Pregnancy
  • Concomitant pathologies causing immunosuppression
  • Concurrent Immunomodulatory therapies
  • Hormone replacement therapy
  • High-grade Cervical Lesions (H-SIL) or in situ adenocarcinoma
  • Previous history of L-SIL or higher grade lesions ≥ 24 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Paolo Giaccone" Hospital

Palermo, 90127, Italy

RECRUITING

MeSH Terms

Interventions

epigallocatechin gallate

Study Officials

  • Antonio Simone Laganà, M.D., Ph.D.

    University of Palermo

    PRINCIPAL INVESTIGATOR

  • Giuseppe Mascellino, M.D.

    University of Palermo

    STUDY CHAIR

  • Pietro Serra, M.D.

    University of Palermo

    STUDY CHAIR

  • Andrea Etrusco, M.D.

    University of Palermo

    STUDY CHAIR

Central Study Contacts

Antonio Simone Laganà, M.D., Ph.D.

CONTACT

+39 3296279579antoniosimone.lagana@unipa.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 15, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)