Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

Exclusion Criteria

• •1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
• •2. Use of any treatment for menopausal symptoms or other concomitant treatments listed.
• •3. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• •4. Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
• •5. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
• •6. History of cancer (except localized skin cancer without metastases) within two years prior to screening.
• •7. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
• •8. History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, gastric bypass procedures, or pancreatic insufficiency).
• •9. Active vaginal infections/abnormalities (e.g., active urinary tract infection (UTI), genital hemorrhage of unknown origin, pelvic inflammatory disease (PID)). Note: screened participants with infections would be eligible to participate two weeks after completing their treatment (wash-out period).
• •10. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
• •11. Major surgery in three months prior to screening or planned major surgery during the study.
• •12. History of alcohol or substance abuse in the last 5 years.
• •13. Use of any vaginal medications, cooling devices, cooling mattresses, cooling sprays, or patches purposed for hot flash control (i.e., V-qool patch, estrogen cream, etc.) one week before and during study. Note: Screened participants that are willing to undergo a washout of at least two weeks or possibly longer and abstain from using above products during the duration of their participation will be enrolled.
• •14. Previous participation in a Bonafide Health run clinical trial on Hot Flashes using Bonafide HF-3.0.
• •15. Participation in another clinical or research trial.
• •16. Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
• •17. Currently incarcerated prisoners.