Effect of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on HPV DNA Integration

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

The supplement is a combination of four natural molecules: Epigallocatechin gallate (EGCG), folic acid (FA), vitamin B12 (B12), and hyaluronic acid (HA).The primary objective is to describe the effect of this association on HPV DNA integration into the host genome by measuring the clearance rate of viral oncoproteins E6 and E7.

A total of 42 women aged 25 or older with persistent HPV infection and low-grade cervical lesions will be randomized 1:1 into two groups.

It had two arms (groups): Treated Group (Pervistop®) (experimental) and Non treated group (no intervention).

Participants in this group will receive no treatment. They will follow standard clinical practice.

The registry classes the interventions as dietary supplement.

More on the Plan

Human Papillomavirus (HPV) is a common sexually transmitted infection that, while often regressing spontaneously, can persist.

Persistent high-risk HPV infection is a major risk factor for cervical cancer because it allows viral DNA to integrate into the host genome.

This integration triggers the constitutive expression of viral oncoproteins E6 and E7, which block the host's tumor suppressor genes (p53 and prb), leading to uncontrolled cell proliferation.Currently, clinical practice for low-grade lesions typically involves a surveillance approach.

This study explores the use of a synergic combination of EGCG (anti-proliferative/pro-apoptotic), Vitamin B12 and Folic Acid (methylation agents), and Hyaluronic Acid (epithelial integrity) to promote viral clearance and inhibit E6/E7 expression.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to women only aged from 25 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 25 years old. Positive HPV DNA test with genotyping 9-24 months prior to Day 0. Positive HPV DNA test with genotyping at Day 0. Presence of an HPV-related cervical lesion within 5-24 months prior to Day 0. This lesion will be defined alternatively as:. Pap test: LSIL, ASC-US.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: high grade cervical lesions (hsil); ongoing pregnancy, evaluated through a rapid chromatographic immunoassay for qualitative detection of hcg in urine; ongoing breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-07 with completion listed for 2027-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of clearance of viral oncoproteins E6 and E7 (time frame: 6 months).

It also tracked 2 secondary outcomes, for example HPV DNA Clearance Rate and Treatment Adherence score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 42 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.