Hot FlashesNCT07408115

Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women

A study testing JDS-HF3.0 in people with Hot Flashes and Hot Flash, run by Bonafide Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 70 years, women only
Conditions the study is for: Hot Flashes, Hot Flash, Hot Flushes, Menopause, Postmenopause
What is being tested?: JDS-HF3.0
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteUnited States
Study dates: 24 May 2024to 18 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 17Show fewer

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.
Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Currently incarcerated prisoners.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bonafide Health
Harrison, New York, 10528

Other trials in United States

About this study

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

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.

Read the 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
Being tested: JDS-HF3.0
Keywords: Postmenopausal, Post menopause, Vasomotor Symptoms, Night sweats, Hot Flashes, Hot Flushes, Non-hormonal Treatment, Supplement
Medical subject headings: Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JDS-HF3.0Dietary supplement
Active Supplement JDS-HF3.0

Study groups in NCT07408115
Study group	Role	What they receive
Active: JDS-HF3.0 Active Group	Experimental	All participants supplementing with JDS-HF3.0 Receives: Dietary Supplement: JDS-HF3.0

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) assesses self-reported perceptions of sleep, including difficulties and concerns with getting to sleep or staying asleep, satisfaction of sleep, and overall sleep quality. This form does not focus on symptoms of specific sleep disorders; it is universal rather than disease-specific. It assesses sleep disturbance over the past seven days
Measured: 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)
The MENQOL is a quality-of-life questionnaire that is specific to postmenopausal women.There are 29 questions that ask questions pertaining to symptoms or problems that are directly related to menopause. Each question being scored from 0 to 6, 0 being not at all bothered and 6 being extremely bothered, with 6 being the worse outcome.
Measured: 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
Change from baseline in scores in the Joint Questionnaire. The Joint Questionnaire is a modified version of the validated Musculoskeletal Questionnaire to include more relevant and joint pain/discomfort specific questions. The questionnaire contains eight questions focused on joint and/or muscular pain, discomfort, and or soreness in the past two weeks. Questions include multiple-choice answers based on severity and frequency.
Measured: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202418 Dec 2024

First posted12 Feb 2026
Study start24 May 2024
Primary completion18 Dec 2024
Study completion18 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Hot FlashesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07408115
Sponsor's protocol ID: BH-HF-BT-0003
Status last verified: Feb 2026
First submitted: 24 Nov 2025
Last updated: 12 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be privately owned.

Publications

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.
PubMed 15345062
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.
PubMed 18521049
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.
PubMed 26271251
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.
PubMed 30211382
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.
PubMed 8844630
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.
PubMed 22250775
Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
PubMed 9643514
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.
PubMed 11738160
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.
PubMed 19408172
https://doi.org/10.1177/20533691231172565
Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.
PubMed 19434881
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.
PubMed 31775595
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.
PubMed 31987231
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.
PubMed 22870045
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.
PubMed 16083502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer

All Hot Flashes trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of the Dietary Supplement Bonafide-HF3.0 on Women Who Experience Vasomotor Symptoms: An Open Label Experience Trial
ClinicalTrials.gov ID: NCT07408115
Acronym / sponsor ID: BH-HF-BT-0003
Conditions: Hot Flashes, Hot Flash, Hot Flushes, Menopause, Postmenopause, Hot Flushes and/or Sweats, Hot Flushes, Night Sweats
Keywords: Postmenopausal, Post menopause, Vasomotor Symptoms, Night sweats, Hot Flashes, Hot Flushes, Non-hormonal Treatment, Supplement
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Bonafide HealthIndustry (pharma, biotech, devices)
Study start: 24 May 2024 (actual)
Primary completion: 18 Dec 2024 (actual)
Study completion: 18 Dec 2024 (actual)
First posted: 12 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active: JDS-HF3.0 Active Group	Experimental	Dietary Supplement: JDS-HF3.0All participants supplementing with JDS-HF3.0

Who may qualify

Ages: 40 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (17 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JDS-HF3.0Active Supplement JDS-HF3.0	Dietary supplement	Active: JDS-HF3.0 Active Group

Primary outcome

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.
Time frame: 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 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)
Change from Baseline on Hot Flash Symptoms assessed via Hot Flash Related Daily Interference Scale (HFRDIS) scores.
Time frame: 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).
Time frame: 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 to one of the ends of the scale. Response options range from 0-100, with a higher score reflecting the worse outcome.
Change from Baseline on Overall Menopausal Symptoms assessed via the Greene Climacteric Scale (CGS).
Time frame: 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 a worse outcome.
Change from Baseline on Overall Menopausal Symptoms assessed via the Menopause Rating Scale (MRS).
Time frame: 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.
Change from Baseline on Overall Menopausal Symptoms assessed via the Visual Analog Scale Vasomotor Symptoms Questionnaire (VAS).
Time frame: 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 to one of the ends of the scale. Response options range from 0-100, with a higher score reflecting the worse outcome.

3 secondary outcomes

Change from Baseline of Sleep Quality assessed via the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF).
Time frame: 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)
Time frame: 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
Time frame: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Background: PubMed 15345062Heinemann 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.
Background: PubMed 18521049Thurston 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.
Background: PubMed 26271251Sussman 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.
Background: PubMed 30211382Delgado 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.
Background: PubMed 8844630Hilditch 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.
Background: PubMed 22250775Yu 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.
Background: PubMed 9643514Greene JG. Constructing a standard climacteric scale. Maturitas. 1998 May 20;29(1):25-31. doi: 10.1016/s0378-5122(98)00025-5.
Background: PubMed 11738160Carpenter 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.
Background: PubMed 19408172Scoglio 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.
Backgroundhttps://doi.org/10.1177/20533691231172565
Background: PubMed 19434881Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.
Background: PubMed 31775595Bannu 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.
Individual participant dataSharing planned: No. Data will be privately owned.

Related trials for Hot Flashes

RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing JDS-HF3.0 in people with Hot Flashes and Hot Flash, run by Bonafide Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From enrollment to initial end of study at 8 weeks and/or end of study at optional 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408115, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.