Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

What this trial studies

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.

Conditions in scope

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

Interventions

• JDS-HF3.0 (Dietary Supplement) — Active Supplement JDS-HF3.0

Who can join

Women only · Ages 40 Years to 70 Years

Inclusion criteria

• 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.
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
• Agree to refrain from treatments listed in the defined timeframe.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion criteria

• Individuals who are lactating, pregnant, or planning to become pregnant during the study.
• Use of any treatment for menopausal symptoms or other concomitant treatments listed.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
• Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).
• History of cancer (except localized skin cancer without metastases) within two years prior to screening.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
• 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).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-05-24
• Primary completion: 2024-12-18
• Last update posted: 2026-02-12
• First posted: 2026-02-12

Sponsor & contact

Lead sponsor: Bonafide Health (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change from Baseline on Hot Flash Symptoms assessed by the number and severity of hot flashes and times awakened at night due to night sweats collected via participant diary tracking electronically. (From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks)
  Study diary will be completed by participants daily from Day -7 to -1 to establish a pre-dose baseline and then from Day 1 to Day 28 ± for the initial study duration. If a participant participates in the optional extension, they will be asked to continue completing the diaries for an additional 56 ± 3 days, for a total of…
• Change from Baseline on Hot Flash Symptoms assessed via Hot Flash Related Daily Interference Scale (HFRDIS) scores. (From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks)
  The HFRDIS measures the impact of hot flashes on overall quality of life and nine specific activities (work, social activities, sleep, mood, leisure activities, concentration, enjoyment of life, sexuality, and relations with others).The rating scale ranges from 0-10, with 0 being does not interfere, and 10 being completely interferes. A higher score indicates a worse outcome.
• Change from Baseline on Hot Flash Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS). (From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks)
  The Visual Analog Scale (VAS) has symptoms recorded on a 10-cm line that represents a continuum between the two ends of a scale -"not bothered" on the left end (0cm) of the scale and "extremely bothered" on the right end (10 cm) of the scale. Subjects mark one point on that continuum, and researchers measure the distance from that point…
• Change from Baseline on Overall Menopausal Symptoms assessed via the Greene Climacteric Scale (CGS). (From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks)
  The GCS was a scale created to be a brief and standardized method to measure climacteric symptoms or complaints. Each of the 21 items is scored between 0-3, with 0 being not at all bothered and 3 being extremely bothered. There are three sub-scales that are measured, which include vasomotor, physical and psychological symptoms. Responses with a higher score reflect…
• Change from Baseline on Overall Menopausal Symptoms assessed via the Menopause Rating Scale (MRS). (From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks)
  The MRS is a self-administered scale that scores eleven items on a 5-point scale, with 0 being no complaints and 4 being very severe symptoms. Each question is rated on a 5-point scale, with the higher number correlating with the more severe symptoms and worse outcome.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.