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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05625308
Other study ID # HPV-NAT-COM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 2, 2022

Study information

Verified date November 2022
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2, 2022
Est. primary completion date November 9, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Clinica Alma Res Roma

Sponsors (1)

Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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