The Effect of Natural Molecules on HPV Infection | NCT06661083

Studies
The Effect of Natural Molecules on HPV Infection

NCT06661083

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Status

Completed

Last Update Posted

Mar 19, 2025Actual

Enrollment

106Actual

Phase

Not Applicable

Conditions

HPV (Human Papillomavirus)-associated

Interventions

EGCG, FA, HA, B12

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Feb 28, 2025Actual

Completion Date

Mar 7, 2025Actual

First Submitted Date

Oct 23, 2024

First Submission Date that Met QC Criteria

Oct 25, 2024

First Posted Date

Oct 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with HPV infection	Experimental		Dietary Supplement: EGCG, FA, HA, B12

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EGCG, FA, HA, B12	Dietary Supplement	EGCG + FA + HA + B12 (1 cps /die)	Patients with HPV infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HPV DNA test negativity	Percentage	6 months of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HPV DNA test positivity
over 18 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D030361	Papillomavirus Infections

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C045651	epigallocatechin gallate
D014805	Vitamin B 12

Ancestor Terms

ID	Term
D045728	Corrinoids
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided