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OpenTrials
Completed

NCT Number: NCT05625308

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

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.

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Key information

Conditions

Papilloma Cervix Lesion Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alma Res

Roma, 00198, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epigallocatechin gallate, Folic acid, Vitamin B12, and Hyaluronic Acid

Dietary 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.

Primary outcomes

  1. Regression of cervical lesions

    Time frame: 12 weeks

    The actual outcome was to measure the rate of regression of the lesions, from moderate to mild, from mild to none.

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2022
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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