NCT07408115

Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

Effect of the Dietary Supplement Bonafide-HF3.0 on Women Who Experience Vasomotor Symptoms: An Open Label Experience Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Bonafide Health · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the efficacy of a neurokinin 1,3 antagonist on improving vasomotor symptoms (VMS) and overall menopause symptoms in women between the ages of 40-70. The primary research question is whether taking the study product daily for 4 weeks with an optional 8 week extension, significantly reduces the severity and frequency of menopause-related symptoms.

Detailed description

About 200 women across the U.S. will take part in this open label trial. All participants will take the study product and will be instructed to consume two tablets each morning for 4 weeks. Participants will be offered the option to enroll in an 8 week extension after the 4 week supplementation period. During this extension, participants will be asked to continue supplementing with the study product at the same dosing regimen. If a participant opts out of the extension, the total time the participant will be in the study is 5 weeks, including baseline data collection. If a participant opts into the 8 week extension, the total time the participant will be in the study is 12 weeks. This is a remotely-delivered trial with no in-person assessments. Participants will take part in four virtual check-ins, including a pre-screening visit, a screening visit, a baseline visit, and a initial end of study visit. If a participant opts into the 8 week extension, there will be two additional virtual visits that are each conducted 4 weeks apart, including a end-of-extension visit. Throughout the study, participants will be asked to complete daily diaries and weekly and monthly questionnaires to report on their symptoms and how they are feeling. Questions included in these assessments ask about hot flashes, night sweats, physical comfort, and overall well-being. The study is led by a research team based in Harrison, NY, USA.

Conditions

• Hot Flashes
• Hot Flash
• Hot Flushes, Menopause, Postmenopause
• Hot Flushes and/or Sweats
• Hot Flushes
• Night Sweats
• Vasomotor Symptoms
• Vasomotor Symptoms (VMS)
• Vasomotor Symptoms Associated With Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	JDS-HF3.0	Active Supplement JDS-HF3.0

Timeline

• Start date: 2024-05-24
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States