Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

NCT07408115 | Completed

• 1 other identifier: BH-HF-BT-0003
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

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

Keywords

Postmenopausal; Post menopause; Vasomotor Symptoms; Night sweats; Hot Flashes; Hot Flushes; Non-hormonal Treatment; Supplement

Outcome Measures

Primary Outcomes (6)

• 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.

  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 84 ± 3 days. The information recorded will be the number and severity of hot flashes that occurred, the number of night sweats and severity, any changes in concomitant medication/dietary supplement information, and any changes in health (Day 1 to 84 ± 3). Efficacy outcomes include daily diary results (number and severity of hot flashes and number of times awakened at night due to night sweats)

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline on Hot Flash Symptoms assessed via Hot Flash Related Daily Interference Scale (HFRDIS) scores.

  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.

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline on Hot Flash Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS).

  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 to one of the ends of the scale. Response options range from 0-100, with a higher score reflecting the worse outcome.

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline on Overall Menopausal Symptoms assessed via the Greene Climacteric Scale (CGS).

  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 a worse outcome.

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline on Overall Menopausal Symptoms assessed via the Menopause Rating Scale (MRS).

  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.

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline on Overall Menopausal Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS).

  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 to one of the ends of the scale. Response options range from 0-100, with a higher score reflecting the worse outcome.

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Secondary Outcomes (3)

• Change from Baseline of Sleep Quality assessed via the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF).

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline of Quality of Life assessed via the menopause-specific quality of life (MENQOL)

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

• Change from Baseline on Joint pain and discomfort assessed via the Joint Questionnaire

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Other Outcomes (1)

• Safety and Tolerability assessed via participant electronic diaries

  From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Study Arms (1)

Active: JDS-HF3.0 Active Group

EXPERIMENTAL

All participants supplementing with JDS-HF3.0

Dietary Supplement: JDS-HF3.0

Interventions

JDS-HF3.0 DIETARY_SUPPLEMENT

Active Supplement JDS-HF3.0

Active: JDS-HF3.0 Active Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Cisgender Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Active vaginal infections/abnormalities (e.g., active urinary tract infection (UTI), genital hemorrhage of unknown origin, pelvic inflammatory disease (PID)). Note: screened participants with infections would be eligible to participate two weeks after completing their treatment (wash-out period).
• 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).
• Major surgery in three months prior to screening or planned major surgery during the study.
• History of alcohol or substance abuse in the last 5 years.
• Use of any vaginal medications, cooling devices, cooling mattresses, cooling sprays, or patches purposed for hot flash control (i.e., V-qool patch, estrogen cream, etc.) one week before and during study. Note: Screened participants that are willing to undergo a washout of at least two weeks or possibly longer and abstain from using above products during the duration of their participation will be enrolled.
• Previous participation in a Bonafide Health run clinical trial on Hot Flashes using Bonafide HF-3.0.
• Participation in another clinical or research trial.

Sponsors & Collaborators

• Bonafide Health: lead

Study Sites (1)

Bonafide Health

Harrison, New York, 10528, United States

Location

Related Publications (16)

• Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.

  PMID: 15345062 BACKGROUND

• Thurston RC, Bromberger JT, Joffe H, Avis NE, Hess R, Crandall CJ, Chang Y, Green R, Matthews KA. Beyond frequency: who is most bothered by vasomotor symptoms? Menopause. 2008 Sep-Oct;15(5):841-7. doi: 10.1097/gme.0b013e318168f09b.

  PMID: 18521049 BACKGROUND

• Sussman M, Trocio J, Best C, Mirkin S, Bushmakin AG, Yood R, Friedman M, Menzin J, Louie M. Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health. 2015 Aug 13;15:58. doi: 10.1186/s12905-015-0217-y.

  PMID: 26271251 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

  PMID: 8844630 BACKGROUND

• Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. Development of short forms from the PROMIS sleep disturbance and Sleep-Related Impairment item banks. Behav Sleep Med. 2011 Dec 28;10(1):6-24. doi: 10.1080/15402002.2012.636266.

  PMID: 22250775 BACKGROUND

• Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.

  PMID: 9643514 BACKGROUND

• Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.

  PMID: 11738160 BACKGROUND

• Scoglio S, Benedetti S, Canino C, Santagni S, Rattighieri E, Chierchia E, Canestrari F, Genazzani AD. Effect of a 2-month treatment with Klamin, a Klamath algae extract, on the general well-being, antioxidant profile and oxidative status of postmenopausal women. Gynecol Endocrinol. 2009 Apr;25(4):235-40. doi: 10.1080/09513590802632506.

  PMID: 19408172 BACKGROUND

• https://doi.org/10.1177/20533691231172565

  BACKGROUND

• Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.

  PMID: 19434881 BACKGROUND

• Bannu SM, Lomada D, Gulla S, Chandrasekhar T, Reddanna P, Reddy MC. Potential Therapeutic Applications of C-Phycocyanin. Curr Drug Metab. 2019;20(12):967-976. doi: 10.2174/1389200220666191127110857.

  PMID: 31775595 BACKGROUND

• Ataei-Almanghadim K, Farshbaf-Khalili A, Ostadrahimi AR, Shaseb E, Mirghafourvand M. The effect of oral capsule of curcumin and vitamin E on the hot flashes and anxiety in postmenopausal women: A triple blind randomised controlled trial. Complement Ther Med. 2020 Jan;48:102267. doi: 10.1016/j.ctim.2019.102267. Epub 2019 Nov 26.

  PMID: 31987231 BACKGROUND

• Umland EM, Falconieri L. Treatment options for vasomotor symptoms in menopause: focus on desvenlafaxine. Int J Womens Health. 2012;4:305-19. doi: 10.2147/IJWH.S24614. Epub 2012 Jul 5.

  PMID: 22870045 BACKGROUND

• Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005 Aug 5;3:47. doi: 10.1186/1477-7525-3-47.

  PMID: 16083502 BACKGROUND

• Menopause, 2017, U.S. Food and Drug Administration/Center for Drug Evaluation and Research: Washington, DC. Accessed.

  BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Trisha VanDusseldorp, Principle Investigator

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 12, 2026
• Study Start: May 24, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)