Welcome!
We know you might have questions about our research study.
The goal of the Papillex Study is to assess the safety and effectiveness of Papillex a dietary supplement, in promoting the regression of abnormal cervical cells.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the Papillex Study.
In this video, the purpose of this study, the study design, risks and benefits and what is expected from the participant and the if you decide to participate. After listening to this recording, please read the informed consent and assent forms as well as the Frequently Asked Questions. This video is meant for parents, legal guardians and the child to watch together. Some of the words we use in this video are directed more toward the parents/guardians, but that doesn’t mean the information is also not important to the child.
PAPILLEX STUDY Introduction Video
2. ICF & Assent Consent Forms
Please take your time to read through both the ICF form, as you will be required to sign them at your initial screening visit should you qualify for the study.
Please do not sign them in advance as they must be signed at the visit after the study staff are assured all your questions have been answered.
3. Frequently Asked Questions
What is the purpose of this clinic study?
The goal of this study is to assess the safety and effectiveness of Papillex®, a dietary supplement, in promoting the regression of abnormal cervical cells.
What do "randomized" and "triple-blind" mean
- Randomized means participants are assigned by chance—like drawing names from a hat—into one of two groups:
- Papillex® group
- Placebo group
Triple-blind means you, the study team, and the data analysts won’t know which group you’re in. This helps keep the results fair and unbiased.
What do the study product and placebo contain?
- Both are provided in capsule form:
- Papillex® contains a blend of vitamins, antioxidants, and herbal extracts (full ingredient are as follows).
Medicinal Ingredient
Quantity per day for Papillex®
Mixed carotenoids
1800 mcg
Vitamin C (ascorbic acid)
180 mg
Vitamin E (D-alpha tocopheryl acetate)
80 mg AT
Folate (Quatrefolic® (6S)-5-Methyletrahydrofolic acid, glucosamine salt)
960 mcg (folic acid equivalent)
Vitamin B12 (methylcobalamin)
4.8 mcg
Zinc (zinc sulfate)
22 mg
Selenium (selenomethionine)
110 mcg
Green Tea Leaf Extract (decaffeinated; 80% catechins, 50% EGCG, 98% polyphenols)
500 mg
Broccoli Sprout Powder (HiActives®) (standardized to ≥5,000 ppm Sulforaphane)
400 mg
Astragalus (astragalus membranaceus) Root Extract (5:1 extract)
200 mg
Natural all-trans-lycopene
7 mg
Reishi Mushroom Extract (fruiting body; 8:1 extract)
100 mg
- Study product also contains inactive ingredients: rice flour and Hypromellose (a plant-based capsule).
- Placebo ingredients include: Rice flour and hypromellose
How often should I take the study product?
You will take two capsules twice daily with food, a total of four capsules per day:
- Take the first two capsules with your first meal of the day.
- Take the next two capsules with your last meal of the day.
What if I miss a dose?
If you forget to take a dose, you can take it as soon as you remember on the same day, but do not take more than 4 capsules in one day.
What side effect might I experience during the study?
You may experience some side effects such as:
- Digestive issues (e.g., nausea, stomach discomfort, loss of appetite, diarrhea, heartburn)
- Liver-related symptoms (e.g., yellowing of the skin or eyes, dark urine, fatigue, sweating, tiredness)
- Muscle or joint pain, swelling in the limbs
- Skin rashes
- Dizziness
How long is the study?
- The main study lasts about 180 days (6 months) and will involve 6 visits to the study clinic, with phone calls between visits.
- You have the option to continue in an open-label extension for another 6 months.
How long is the study?
- The main study lasts about 180 days (6 months) and will involve 6 visits to the study clinic, with phone calls between visits.
- You have the option to continue in an open-label extension for another 6 months.
What is the open-label extension?
In the open-label extension phase, you will receive the product with the active ingredients. If you choose to continue, your total participation will last up to 360 days and include 7 study visits. This part of the study allows researchers to gather more information over a longer time.
Is there anything I should know before visiting the clinic?
- Avoid MRI, CT scans, X-rays, or other contrast procedures (e.g., iodine, gadolinium) within 48 hours before study Visits 2 and 6.
- Do not donate blood within 30 days prior to enrollment (Visit 2), during the study, or within 30 days after your final visit (Visit 6 or 7).
Can I leave the study at any time?
Yes, your participation is completely voluntary. You can leave the study at any time, for any reason, without penalty or losing access to other care.
What test will I have during the study?
As part of the study, you will undergo:
- Blood tests to check your overall health, including:
Completed Block Count (CBC)
Clinical Chemistry Panel, which includes Vitamin B12, Folate, Zinc and Selenium Levels
Immune markers, such as T lymphocytes and interferon beta (IFNβ)
- Pap smear at Screening (unless you’ve had one within the past 6 months) and at Visit 6
- HPV test to detect the presence of the virus at Screening (unless you’ve had one within the past 6 months) and at Visit 6
- If your HPV results suggest further testing, you may be referred for a Colposcopy, a procedure to examine your cervix more closely
- Individuals of childbearing potential, will have to undergo a Urine Pregnancy Test
What will the study diaries consist of?
You will be required to complete online daily study diaries where you will report study product consumption, any adverse events, and changes in health or medications. If you decide to participate in the extension period, you will be required to complete the study diaries weekly.
What will the questionnaires consist of?
RAND SF-36 (Quality of Life) Questionnaire –This questionnaire will assess your overall health-related quality of life. This will be administered at baseline (Visit 2, Day 0) and all subsequent visits.
Will my personal information be kept private?
Yes, absolutely. All your personal and medical information will be kept confidential to the extent required by law. You will not be identified in any publication that may result from the study.
Will I receive compensation for taking part in the study?
- Yes, you will receive a total of $750 if you complete all study visits and requirements. Payments are made using a Clincard (like a prepaid Mastercard you can use for purchases or ATM withdrawals).
- If you choose to continue and complete the open-label extension for an additional 6 months and attend Visit 7 at the clinic, you will receive an additional compensation of $250
- Processing times may apply before funds become available on your ClinCard.
Who/How do I contact the study staff if I have any questions?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
