Effect of BH-HF3.0 on Vasomotor Symptoms (VMS) in Menopausal Women: A De-Centralized, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
Bonafide-HF3.0
+ Placebo
Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
+ Hot Flashes
Treatment Study
Summary
Study start date: July 9, 2023
Actual date on which the first participant was enrolled.The study aims to explore the effects of a product called Bonafide-HF3.0 on symptoms experienced by women going through menopause, particularly focusing on vasomotor symptoms like hot flashes and night sweats. Menopause often brings about various changes, including mood swings, sleep disturbances, and more. Many women experience these symptoms during menopause, which can significantly affect their quality of life. Current treatments, like hormone replacement therapy, can be effective but may come with risks such as an increased chance of breast cancer. This study targets women aged 40 to 65 who are experiencing menopausal symptoms and seeks to find a safe alternative to hormone therapy using Bonafide-HF3.0, which includes natural ingredients like green tea extract, curcumin, and phycocyanin. Participants in this study will be randomly assigned to receive either Bonafide-HF3.0 or a placebo, meaning they will not know which one they are taking, to ensure unbiased results. The study is designed to compare the effects of the actual treatment against no active treatment. The focus is on observing any changes in the severity and frequency of vasomotor symptoms as well as overall menopausal symptoms. This approach helps determine the effectiveness of Bonafide-HF3.0 in reducing hot flashes and other related symptoms, potentially offering a safer alternative for managing menopause-related discomforts.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 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 65 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.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary 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