Welcome!
We know you might have questions about our research study.
The Menopause Symptoms in Women-Natural Relief Study, is exploring how a product called Graminex® might help to improve menopausal symptoms over a longer period of time.
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 Menopausal 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.
Menopause Symptoms- A Natural Relief 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 study?
Menopause is a natural transition in women diagnosed by the absence of a menstrual cycle for 12 months, with common symptoms ranging from hot flashes, night sweats, mood disturbances, and poor sleep quality. Severity of symptoms can impact quality of life, productivity, and increase risk of heart, blood vessels, and mental health disorders. Existing therapies such as Hormone replacement therapy, antidepressants, and anticonvulsants for managing menopausal symptoms come with side effects, so there is a need for alternative safer and effective strategies.
Pollen extract contains amino acids, carbohydrates, fats, vitamins and minerals responsible for alleviating menopausal symptoms. Previous studies on pollen extract have shown meaningful reduction in hot flashes, sleep disturbances, mood, irritability, fatigue, vaginal dryness, and muscle and joint pain. These results show potential for the Graminex study product to improve menopausal symptoms over a longer period of time.
Therefore, the purpose of this study is to investigate the effect of pollen extracts on menopausal symptoms in healthy women over a 36-week or approximately 252-day period.
What is the study product? What is in it?
The study product is a flower pollen extract in capsule form. There are two types active products in this study: Graminex water soluble pollen extract capsules, and Graminex lipid soluble pollen extract capsules. The placebo is a capsule containing non-medicinal ingredients. Please see the full ingredient list below:
The Graminex® study products contain a standardized extract consisting of rye pollen (Secale cereale).
Study Product: Graminex WSPE® (Water Soluble Pollen Extract Capsules)
|
Medicinal Ingredient |
Quantity per capsule (Qty) |
|
Graminex Water Soluble Pollen Extract |
150 mg |
Non-medicinal ingredients: gelatin, microcrystalline cellulose, maltodextrin, stearic acid, titanium dioxide, silicon dioxide
Study Product: Graminex LSPE® (Lipid Soluble Pollen Extract Capsules)
|
Medicinal Ingredient |
Quantity per capsule (Qty) |
|
Graminex Lipid Soluble Pollen Extract |
36 mg |
Non-medicinal ingredients: gelatin, microcrystalline cellulose, maltodextrin, silicon dioxide, stearic acid, titanium dioxide
Placebo Ingredients: gelatin, microcrystalline cellulose, maltodextrin, silicon dioxide, hydroxypropyl cellulose, calcium stearate, titanium dioxide
Are there any side effects?
There may be unknown risks or side effects in taking the study product. Potential known side effects include:
- Gastrointestinal/abdominal discomfort (such as pain, bloating, nausea, vomiting, heartburn)
- Allergic skin reactions
Allergic Reactions
- It is possible for allergic reactions to occur. For your safety, you cannot join this study if you have asthma and/or have any allergy (including bee products or pollen), sensitivity, or intolerance to the study products or placebo ingredients. If you have serious allergic reactions, you could die. Please carefully read the study products ingredients and ensure you are not allergic to any. Some effects of an allergic reaction that could be signs of a life-threatening condition (anaphylaxis) include:
- Rash
- Difficulty breathing
- Wheezing
- Sudden drop in blood pressure (dizziness, lightheaded)
- Swelling around mouth, throat, or eyes
- Rapid or fast pulse
- Sweating
How often and when do I need to take the study product?
You will take one capsule twice daily with breakfast and dinner for the duration of the study starting on Day 1. If you miss a dose, please take the missed dose as soon as you remember, on the same day. Do not take more than two capsules per day.
Please save all unused and open packages and return them at each study visit to determine if you are taking the study product properly.
How/when will I receive the product?
If you are eligible to be enrolled in the study, the product will be provided at no cost to you at your first study visit.
How long will the study last?
If you are enrolled in the study, your participation will last for 36 weeks or approximately 252 days, with 5 study visits in total. In addition, study staff will reach out to you between visits. If you are eligible to be enrolled in the study, the product will be provided at no cost to you at your first study visit.
What does randomization mean
Randomization is a process of assigning participants to different groups by chance (like flipping a coin). If eligible, you will be enrolled into the study and will be randomized into 1 of 3 groups:
- Graminex Water Soluble Pollen Extract group
- Graminex Lipid Soluble Pollen Extract group
- Placebo group
This is a triple-blind study, meaning neither you, clinic staff, nor the researchers analyzing the data will be aware of which group you have been assigned to. This ensures study results are unbiased. Neither you nor clinic staff can choose which group you are in, ensuring the integrity of the trial. However, should it become necessary for health reasons, staff can access this information.
What does randomization mean
Randomization is a process of assigning participants to different groups by chance (like flipping a coin). If eligible, you will be enrolled into the study and will be randomized into 1 of 3 groups:
- Graminex Water Soluble Pollen Extract group
- Graminex Lipid Soluble Pollen Extract group
- Placebo group
This is a triple-blind study, meaning neither you, clinic staff, nor the researchers analyzing the data will be aware of which group you have been assigned to. This ensures study results are unbiased. Neither you nor clinic staff can choose which group you are in, ensuring the integrity of the trial. However, should it become necessary for health reasons, staff can access this information.
What is a placebo?
A placebo is a capsule that looks like the study product but has no active/medicinal ingredients. It is used in research to help determine if a study product or treatment has any real effect in comparison to non-treatment. It also ensures reliability of results by reducing bias as neither participants nor staff are aware of who receives the study product.
Do I have to come into the clinic for any assessments?
Yes, you will have 5 in-person visits over a 36-week or approximately 252-day period. Assessments will include Height, Weight, Blood pressure, and Heart rate measurements. You will also complete questionnaires.
Do I need to bring anything with me to a clinic visit?
You will need to present the clinic with a valid piece of photo ID. You must also bring with you all unused and open study products and packaging, along with completed study diaries if applicable.
What is the compensation for participating?
For your time, you will be compensated a total of $800 if you complete the entire study and all associated requirements. You become eligible for compensation only if you qualify during your first visit and are enrolled in the study. Please note that attending the first visit does not guarantee enrollment. If you are enrolled, you will be compensated for visits that you have completed.
- *Please note, if you complete visit 1 and are not enrolled into the study for any reason, you will not be compensated for this visit. If you decide to stop participating at any time, please let study staff know or contact us by email at clinic@kgkscience.com
How and when will I receive my compensation for participating?
During the final visit after completion of the study, a Clincard will be given to you. A Clincard works similarly to a prepaid credit card that can be used anywhere that accepts Mastercard. The funds may also 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 study staff will keep all of your medical information confidential to the extent required by law. You will not be identified in any publication that may result from the study.
Who/how do I contact the study staff if I have any questions?
If you have any questions or concerns, please 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
