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:
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 clinical trial?
- Abnormal cervical cells are classified based on where the changes are happening and how serious those changes are. Sometimes, these abnormal cells can go back to normal on their own. However, there is a risk that these cells could develop into cervical cancer. According to the World Health Organization, cervical cancer is the fourth most common cancer in women. This is why it’s important to detect and manage abnormal cervical cells early.
- Currently, removing abnormal cervical cells requires invasive procedures, such as cutting out the cells (excision) or destroying them with heat or cold (ablation). These treatments can lead to risks like infection, bleeding, scarring of the cervix, and potential pregnancy complications. Because of these risks, it’s beneficial to explore safer treatment options.
- The study product Papillex® is a dietary supplement. Previous research studies suggest it may help positively improve abnormal cervical cells. However, the specific study product formulation needs further investigation. The objective of this study is to examine the safety and efficacy of Papillex® on improving abnormal cervical cells caused by HPV.
What is the study product? What is in it?
- 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
Are there any side effects?
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 often and when do I need to take study product?
- The first 2 capsules should be taken with your first meal of the day and the second 2 capsules should be taken with your last meal of the day.
- If you forget to take the product, you should take it as soon as you remember on the same day.
- Please do not exceed 4 capsules daily.
- Save all unused and open packages and return them to KGK Science Inc. for a determination of compliance.
How/when will I receive the product?
- You will receive the study product during your day 0 randomization appointment.
How/when can I find out if I got the study product or the placebo?
- This study is designed to be triple-blinded. That means during the study neither you, the study staff, nor the researchers analyzing the data will know if you are taking the study product or placebo.
- If you are interested in learning if you received the product or placebo, we can let you know at a later date, when all participants have completed the study and statistical analysis of the data has been completed.
How long will the study last?
- Once you receive your study product your participation will continue for approximately 360 days
What does randomization mean?
- Randomized means that you will be assigned by chance, like flipping a coin, to a study group (either the study product or the placebo).
- This is a triple-blind study, so neither you, the study doctor, nor the researchers analyzing the data will know which group you have been randomized to or which product you will receive (study product or placebo). We will dispense study products based on randomization.
Do I have to come into the clinic for any assessments?
- Yes, there will be 7 visits over 360 days
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).
What assessments are associated with this study?
- Pap Smear and HPV test at Visits 1, 6 and 7
- Blood Sample collection and testing on visits 1, 2, 4 and 6
- Questionnaires and surveys at visits 2, 3, 4, 5, 6, 7
Who/how do I contact 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
What is the compensation for participating?
For your time and participation in the study, you will be compensated a total of 1000$ if you complete the entire study and all associated requirements.
How and when will I receive my compensation for participating?
- After completion of the study, you will receive your compensation on a ClinCard. You will receive the Clincard at your final visit.
- Your ClinCard is a prepaid credit card that can be used anywhere that accepts Mastercard, or the funds can be withdrawn from an ATM (ATM fees apply). Processing times may apply before funds become available on your ClinCard.
Is my participation confidential?
Yes! KGK Science research staff will keep all of your personal medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.
For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
