NCT05625308

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

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

July 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2022

Completed
Last Updated

December 22, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

November 15, 2022

Last Update Submit

December 21, 2022

Conditions

PapillomaCervix Lesion

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

Control

NO INTERVENTION

Untreated women.

Interventions

Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic AcidDIETARY_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.

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

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HPV infections
  • Occurrence of low-grade cervical lesions

You may not qualify if:

  • Diagnosis of malignancy or severe cervical lesions
  • Concurrent uterine pathologies
  • Pregnancy or intended to seek pregnancy in the next three months
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alma Res

Roma, 00198, Italy

Location

MeSH Terms

Conditions

Papilloma

Interventions

epigallocatechin gallateFolic AcidVitamin B 12Hyaluronic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Squamous CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Cesare Aragona, MD

    Clinica Alma Res

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 22, 2022

Study Start

July 1, 2022

Primary Completion

November 9, 2022

Study Completion

December 2, 2022

Last Updated

December 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)