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

Papilloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05625308
• Other study ID #: HPV-NAT-COM
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cervix Lesion
• Papilloma

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