Completed

Bonafide-HF3.0 Dietary Supplement for Vasomotor Symptoms in Women

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Study Aim

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.

What is being tested

JDS-HF3.0

Dietary Supplement
Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Hot Flashes

From 40 to 70 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorBonafide Health
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

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).

Official TitleEffect of the Dietary Supplement Bonafide-HF3.0 on Women Who Experience Vasomotor Symptoms: An Open Label Experience Trial
Principal SponsorBonafide Health
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

112 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Signs and SymptomsPathological Conditions, Signs and SymptomsHot Flashes

Criteria

7 inclusion criteria required to participate
Healthy women who are 40 to 70 years of age (inclusive).

Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).

Have self-reported menopausal symptoms for the past 6 months.

Have self-reported ≥5 moderate to severe hot flashes per day, on average for 7 days.

Show More Criteria

17 exclusion criteria prevent from participating
History of alcohol or substance abuse in the last 5 years.

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).

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).

Participation in another clinical or research trial.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All participants supplementing with JDS-HF3.0

Study 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

Suspended

Bonafide Health

Harrison, United StatesOpen Bonafide Health in Google Maps
CompletedOne Study Center
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