RecruitingNot ApplicableNCT06979180

A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.

A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV


Sponsor

Papillex Inc.

Enrollment

60 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to investigate the safety and efficacy of Papillex® on the regression of abnormal cervical cells caused by HPV in women with a cervical intraepithelial neoplasia (CIN) 1 or 2 diagnosis. The main question it aims to answer is: Is there a difference in the proportion of participants with a regression in CIN based on histology or cytology from baseline at day 180 between Papillex® and placebo? Participants will be asked to consume Papillex® or placebo for 180 days, complete questionnaires, a PAP smear, HPV test, and colonoscopy (where applicable).


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a natural health supplement called Papillex in women with abnormal cervical cells (cervical intraepithelial neoplasia, or CIN) that are also positive for high-risk HPV (human papillomavirus). The goal is to see whether this supplement can help the immune system clear the HPV infection and normalize the cervical cells. **You may be eligible if...** - You are a woman between 25 and 55 years old - You have been diagnosed with CIN1 or higher with concurrent high-risk HPV positivity, and the diagnosis has been present for more than 12 months - You are either post-menopausal, have had permanent sterilization, or are using a reliable form of contraception **You may NOT be eligible if...** - Your cervical cell abnormality or HPV positivity has not been present for at least 12 months - You have another concurrent cancer - You are pregnant or planning to become pregnant - You are currently taking medications or supplements that may interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPapillex®

Participants will be instructed to take two capsules twice daily with food, with the first dose taken with the first meal of the day and the second dose taken with the last meal of the day.

OTHERPlacebo

Participants will be instructed to take two capsules twice daily with food, with the first dose taken with the first meal of the day and the second dose taken with the last meal of the day.


Locations(1)

KGK Science Inc.

London, Ontario, Canada

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NCT06979180


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