A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome

Prior treatment

• Current use of an extended activity hormonal contraception (examples include Depo-Provera injection, Nexplanon implant, or hormonal intrauterine devices (IUDs)).
• Anyone who has an alcohol dependency, regularly uses cannabis, or is using illicit drugs.
• Anyone currently taking prescription pain medication for any indication.
• Anyone who is currently taking, or planning to take during the study period, any medications, supplements or products targeted at improving Premenstrual Syndrome symptoms.

Other illness

• Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
• Anyone diagnosed with Graves disease, Hashimotos or taking any medication for their thyroid.
• Anyone with any allergic reactions requiring the use of an Epi-pen.
• Anyone with known severe allergic reactions, or history of allergy or intolerance to ingredients found in over-the-counter dietary, vitamin or herbal supplements.
• Anyone with any allergies or sensitivities to any of the study product ingredients.
• Anyone with known allergies to nightshades (e.g., eggplant, tomato, bell pepper, potato).
• Anyone with a history of substance abuse.

Other

• Anyone currently undergoing or planning to undergo during the study period, any gynecological-related procedures.
• Anyone who has undergone any surgeries or invasive treatments in the last six months, or is planning to during the study period.
• Unwilling to follow the study protocol.
• Anyone pregnant, breastfeeding, or trying to conceive currently or for the duration of the study.
  • Participants will self-report that they are not pregnant.
• Currently participating in any other clinical study or planning to at any point during this study's duration.
• Anyone who regularly takes supplements that might reduce inflammation or is planning to at any point during the study period.

• Female 18+ years of age.
• Must be in good health with no significant chronic conditions (such as oncological or psychiatric disorders) and a BMI under 35.
• Must experience at least five of the following symptoms during their menstrual cycle:
  • Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances
• Must have a regular menstrual cycle with a bleed week, and must be currently tracking their menstrual cycle and able to accurately predict their bleed week.
• If using hormonal contraception, must do so for at least three months before starting the trial, and remain consistent with taking it as per healthcare provider instructions during the study.
• If using hormonal contraception, must allow for a bleed week every month.
• Must agree to avoid cannabis, CBD, ashwagandha, and supplements other than multivitamins or protein powders for 24 hours prior to the study, and during the full study duration.
• Willing to refrain from OTC pain medications or supplements to target period-related symptoms during the study period.
• Must live in the United States.