Testing Papillex® for CIN - cervical intraepithelial neoplasia

Exclusion

• −Allergy, sensitivity, or intolerance preventing consumption of investigational product or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → ingredients
• −Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
• −Currently undergoing treatment for CIN, are indicated for treatment during the study period, have received treatment (e.g., conization or loop electrosurgical excision procedure) within the last five years, or have active CIN 3
• −Concurrent uterine pathologies
• −History of hysterectomy or destructive therapy of the cervix
• −Cervical cancer
• −Unstable metabolic disease or chronic diseases as assessed by the QI
• −Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• −Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
• −Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• −History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• −Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• −Individuals with an autoimmune disease or are immune compromised
• −Self-reported confirmation of blood/bleeding disorders as assessed by the QI
• −Alcohol intake average of \>2 standard drinks per day as assessed by the QI
• −Alcohol or drug abuse within the last 12 months
• −Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
• −Clinically significant abnormal laboratory results at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → as assessed by the QI
• −Blood donation 30 days prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more →, during the study, or a planned donation within 30 days of the last study visit
• −Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
• −Individuals who are cognitively impaired and/or who are unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• −Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
• −Women who are pregnant, breast feeding, or planning to become pregnant during the study
• −Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• −Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable