Bonafide-HF3.0 Dietary Supplement for Vasomotor Symptoms in Women
This study aims to evaluate the effectiveness of the Bonafide-HF3.0 dietary supplement in reducing hot flash symptoms and improving overall menopausal symptoms in women, by measuring changes in hot flash frequency, severity, and impact on daily life.
JDS-HF3.0
Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
+ Hot Flashes
Treatment Study
Summary
Study start date: May 24, 2024
Actual date on which the first participant was enrolled.This study focuses on the dietary supplement Bonafide-HF3.0 and its effect on women experiencing vasomotor symptoms, such as hot flashes and night sweats. The trial aims to enroll around 200 women across the U.S. who will take two tablets of the supplement every morning for four weeks. An optional eight-week extension is available for participants to continue taking the supplement at the same dose. This study is important as it aims to improve the quality of life for women experiencing menopausal symptoms by reducing the severity and frequency of hot flashes and night sweats. During the study, participants will have virtual check-ins, including a pre-screening visit, a screening visit, a baseline visit, and an initial end-of-study visit. If a participant chooses to join the eight-week extension, two additional virtual visits will be scheduled. Throughout the study, participants will complete daily diaries and weekly and monthly questionnaires to report on their symptoms and well-being. The primary outcomes measured include changes in hot flash symptoms, menopausal symptoms, and overall quality of life, using various scales such as the Hot Flash Related Daily Interference Scale (HFRDIS), the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS), the Greene Climacteric Scale (CGS), and the Menopause Rating Scale (MRS).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.112 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location