Suspended

Effect of BH-HF3.0 on Vasomotor Symptoms (VMS) in Menopausal Women: A De-Centralized, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

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What is being tested

Bonafide-HF3.0

+ Placebo

Dietary Supplement
Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Hot Flashes

From 40 to 65 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2023
See protocol details

Summary

Principal SponsorBonafide Health
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEffect of BH-HF3.0 on Vasomotor Symptoms (VMS) in Menopausal Women: A De-Centralized, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
NCT06289907
Principal SponsorBonafide Health
Last updated: January 28, 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

80 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 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

Signs and SymptomsPathological Conditions, Signs and SymptomsHot Flashes

Criteria

7 inclusion criteria required to participate
Healthy women who are 40 to 65 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 (perimenopause, post-menopause).

Have self-reported at least 5 moderate to severe vasomotor symptoms (hot flashes and/or night sweats) most days of the week.

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16 exclusion criteria prevent from participating
Individuals who are lactating, pregnant, or planning to become pregnant during the study.

Currently incarcerated prisoners

Use of any treatment for menopausal symptoms or other concomitant treatments listed in Section 11.4.

Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.

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Study Plan

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

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity

Group II

Placebo
Placebo capsule containing: * Microcrystalline cellulose * Silicon dioxide micronized * Magnesium stearate

Study 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

Suspended

Lindus Health, Inc.

London, United KingdomOpen Lindus Health, Inc. in Google Maps
SuspendedOne Study Center