Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Completed

CT.gov ID

NCT05625308

Collaborator

(none)

Enrollment

Location

Arms

5.1

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papilloma Cervix Lesion	Dietary Supplement: Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions

Actual Study Start Date :

Jul 1, 2022

Actual Primary Completion Date :

Nov 9, 2022

Actual Study Completion Date :

Dec 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Co-treatment with EGCG, FA, B12, and HA 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 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.
No Intervention: Control Untreated women.

Arm

Intervention/Treatment

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

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

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.

No Intervention: Control

Untreated women.

Outcome Measures

Primary Outcome Measures

Regression of cervical lesions [12 weeks]
The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

HPV infections
Occurrence of low-grade cervical lesions

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Alma Res	Roma		Italy	00198

Sponsors and Collaborators

Lo.Li.Pharma s.r.l

Investigators

Principal Investigator: Cesare Aragona, MD, Clinica Alma Res

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lo.Li.Pharma s.r.l

ClinicalTrials.gov Identifier:

NCT05625308

Other Study ID Numbers:

HPV-NAT-COM

First Posted:

Nov 22, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epigallocatechin gallate

Hyaluronic Acid

Study Results

No Results Posted as of Dec 22, 2022