We’re pleased to announce recruitment is underway for our latest research study.
This remote, double-blind, randomized clinical trial will measure the effectiveness of an herbal blend on menopausal symptoms while also analyzing its impact on quality of life.
For the 12-week study, we are recruiting U.S. women between the ages of 40 and 65 experiencing moderate to severe menopausal symptoms, such as consistent hot flashes or the absence of a regular menstrual cycle (including irregular menstrual cycles of at least 6 months). Potential participants will be asked to complete a pre-screening questionnaire to determine the severity of their symptoms.
This study is considered to be remote, although two brief visits to a pre-approved patient service center are necessary to provide a blood sample. Participants will require a smartphone and access to a reliable internet connection in order to utilize the ObvioHealth app, our proprietary application used to conduct research studies digitally.
Subjects will be asked to consume the investigational product (IP) daily over a 12-week period and report compliance through daily questionnaires in the app. Baseline questionnaires, designed to assess hot flash episodes, feelings of fatigue, and changes in health-related quality of life, will need to be completed periodically throughout the study.
Quality of life can be negatively impacted by the symptoms of menopause. Hot flashes, joint stiffness, depression, anxiety, difficulty sleeping, painful sexual intercourse and mood swings are among some of the more uncomfortable symptoms.
Menopausal hormone therapy (MHT) is the primary treatment for menopause symptoms and involves the use of estrogen alone or estrogen plus progestin. However, MHT does present a certain amount of risk to those who undergo treatment. Various health effects include increased risk of urinary incontinence, development of dementia, and an increased risk of stroke, blood clots, or heart attack.
This study will investigate a non-hormonal treatment, the Ashwagandha root, for its purported positive effects on stress and anxiety – which studies have shown to exacerbate menopause symptoms.
Study sponsors can learn more about the benefits of implementing digital tech in study design by clicking here.