Vasomotor SymptomsNCT05813067
Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women
A study testing JDS-HF 3.0 in people with Vasomotor Symptoms and Postmenopausal Disorders, run by Bonafide Health at 3 sites in United States.
Trial summary
The role of nutrition is recognized as a vital component to healthy aging throughout menopause. The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms, Postmenopausal Disorders
- What is being tested?
- JDS-HF 3.0
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Dec 2022to 23 Apr 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy menopausal women who are 40 to 65 years of age (inclusive).
- Last menstrual period has occurred at least 6 months prior to screening.
- MRS score ≥2 at screening and at baseline.
- Have self-reported menopausal symptoms for the past 6 months.
- Have self-reported at least five moderate to severe hot flashes per day (including night sweats), on average for 7 days
- Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
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- In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
- Have normal vital signs or acceptable to the investigator vital signs (blood pressure and heart rate) at screening.
- Agree to refrain from treatments for hot flashes and other symptoms of menopause.
- 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.
- Induced menopause through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
- Individuals who have had a partial or total hysterectomy.
- Use of any treatment for menopausal symptoms or other concomitant treatments listed under the "concomitant therapies" section of the protocol
- 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).
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- Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., lyme disease, TB, HIV).
- Have uncontrolled high blood pressure (≥160 mmHg systolic or ≥100 mmHg diastolic) or thyroid disease, defined as not taking a stable dose of medication on the current regimen for a minimum of three months.
- Have diabetes (Type I or Type II).
- History of cancer (except localized skin cancer without metastases) within five (5) years prior to screening. Note: all women with breast cancer (active or any history) will be excluded.
- 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 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 four 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 a surgical procedure for the treatment of obesity (e.g., gastric bypass, gastric banding).
- History of alcohol or substance abuse.
- Receipt or use of test product(s) in another research study within 28 days prior to the baseline visit (Day 1), or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Use of any vaginal medications, rinses, moisturizers, cooling devices, cooling mattresses, cooling sprays, or patches purposed for hot flash control (i.e., V-cool patch, estrogen cream, etc.) one week before and during study.
- Current or previous smoker in the last 3 years.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alabama Clinical Therapeutics
Birmingham, Alabama, 35205
Rosemark WomenCare
Idaho Falls, Idaho, 83404
Altus Research
Lake Worth, Florida, 33461
About this study
Official title: The Effects of JDS-HF3.0 on Vasomotor Symptoms in Menopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
The role of nutrition is recognized as a vital component to healthy aging throughout menopause. The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women.
Read the detailed description
Menopause is characterized by the cessation of menstruation for 12 consecutive months. It is a natural phase in which a women's menstrual cycles permanently cease, with the transition often beginning around 50 years of age or older. Menopausal women often experience changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body composition, and vasomotor symptoms (VMS, including hot flashes and night sweats).
VMS can have a negative impact on quality of life by disrupting both sleep and mood. Some management strategies for VMS include hypnosis, and supplementation of vitamin E, black cohosh, and phytoestrogens. However, hormone replacement therapy still remains the most common and effective treatment. Hormone replacement therapy, using estrogen or estrogen-progestin containing products, reduces the frequency and severity of hot flashes by 75-79%. Although hormone replacement therapy is generally well tolerated, it has been linked to an increased risk of breast cancer. Due to this concern it is recommended to use hormone replacement therapy for the shortest duration and lowest dose possible. There is a need for alternative options to help manage VMS in menopausal women, and dietary supplements may fill this role.
The test product (TP) for this study is a dietary supplement containing a proprietary botanical blend containing polyphenols and flavonoids. These herbal ingredients have been previously investigated for various properties, which demonstrate the opportunity to support the quality of life of menopausal women experiencing VMS by improving sleep and mood.
This randomized, double-blind, placebo-controlled, parallel study will be conducted to evaluate the TP for its impacts on healthy menopausal women with VMS.
- Conditions
- Vasomotor Symptoms, Postmenopausal Disorders
- Being tested
- JDS-HF 3.0, Placebo
- Keywords
- Vasomotor Symptoms, Menopause, Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDS-HF 3.0Dietary supplement
Take 2 capsules once daily in the mornings with food
PlaceboDietary supplement
Take 2 capsules once daily in the mornings with food
| Study group | Role | What they receive |
|---|---|---|
| Test Product: JDS-HF3.0 Capsules | Experimental | Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity Receives: Dietary Supplement: JDS-HF 3.0 |
| Placebo Capsules | Placebo comparator | Placebo capsule containing:
* Microcrystalline cellulose
* Silicon dioxide micronized
* Magnesium stearate Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS).
Change from baseline for the number and severity of hot flashes measured by HFRDIS scores.
The HFRDIS has a scoring range of 0-100, with higher values indicating worse symptoms.
Measured: 12 weeks
Secondary outcomes (4)
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Greene Climacteric Scale (GCS).
Change from baseline in GCS scores.
The GCS has 3 sub-domains for scoring. The psychological sub-domain has a scoring range from 0-33, the physical sub-domain has a scoring range from 0-21, and the vasomotor sub-domain has a scoring range from 0-6. Higher values indicate worse symptoms in all 3 sub-domains.
Measured: 12 weeks
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Menopausal Rating Scale (MRS).
Change from baseline in MRS scores.
The MRS has a scoring range of 0-44, with higher values indicating worse symptoms.
Measured: 12 weeks
To determine the effect of the TP compared to the placebo on sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
Change from baseline in PSQI scores.
The PSQI has a scoring range of 0-21, with higher values indicating worse symptoms.
Measured: 12 weeks
To determine the effect of the TP compared to the placebo on quality of life as determined by the Menopause-Specific Quality of Life (MENQOL) questionnaire.
Change from baseline in MENQOL scores.
The MRS has a scoring range of 0-174, with higher values indicating worse symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start27 Dec 2022
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasomotor SymptomsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled, parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonafide Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Samuel N Lederman, MD, Principal investigator, Altus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813067
- Sponsor's protocol ID
- B01-22-01-T0032
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lederman S, Minkin MJ, Doyle AL, Rubio J, Recker S, Lin LX, VanDusseldorp T. Neurokinin pathway botanical antagonist for menopausal vasomotor symptoms: A randomized, double-blind, placebo-controlled study. Maturitas. 2026 Aug;211:109023. doi: 10.1016/j.maturitas.2026.109023. Epub 2026 Jun 10.
PubMed 42284819
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of JDS-HF3.0 on Vasomotor Symptoms in Menopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05813067
- Acronym / sponsor ID
- B01-22-01-T0032
- Conditions
- Vasomotor Symptoms, Postmenopausal Disorders
- Keywords
- Vasomotor Symptoms, Menopause, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bonafide HealthIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 14 Apr 2023 (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.
The role of nutrition is recognized as a vital component to healthy aging throughout menopause. The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women.
Detailed description
Menopause is characterized by the cessation of menstruation for 12 consecutive months. It is a natural phase in which a women's menstrual cycles permanently cease, with the transition often beginning around 50 years of age or older. Menopausal women often experience changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body composition, and vasomotor symptoms (VMS, including hot flashes and night sweats).
VMS can have a negative impact on quality of life by disrupting both sleep and mood. Some management strategies for VMS include hypnosis, and supplementation of vitamin E, black cohosh, and phytoestrogens. However, hormone replacement therapy still remains the most common and effective treatment. Hormone replacement therapy, using estrogen or estrogen-progestin containing products, reduces the frequency and severity of hot flashes by 75-79%. Although hormone replacement therapy is generally well tolerated, it has been linked to an increased risk of breast cancer. Due to this concern it is recommended to use hormone replacement therapy for the shortest duration and lowest dose possible. There is a need for alternative options to help manage VMS in menopausal women, and dietary supplements may fill this role.
The test product (TP) for this study is a dietary supplement containing a proprietary botanical blend containing polyphenols and flavonoids. These herbal ingredients have been previously investigated for various properties, which demonstrate the opportunity to support the quality of life of menopausal women experiencing VMS by improving sleep and mood.
This randomized, double-blind, placebo-controlled, parallel study will be conducted to evaluate the TP for its impacts on healthy menopausal women with VMS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, parallel
| Arm | Type | Receives |
|---|---|---|
| Test Product: JDS-HF3.0 Capsules | Experimental | Dietary Supplement: JDS-HF 3.0Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity |
| Placebo Capsules | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule containing: * Microcrystalline cellulose * Silicon dioxide micronized * Magnesium stearate |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy menopausal women who are 40 to 65 years of age (inclusive).
- Last menstrual period has occurred at least 6 months prior to screening.
- MRS score ≥2 at screening and at baseline.
- Have self-reported menopausal symptoms for the past 6 months.
- Have self-reported at least five moderate to severe hot flashes per day (including night sweats), on average for 7 days
Key exclusion criteria (21 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study.
- Induced menopause through surgery such as bilateral oophorectomy or salpingo-oophorectomy, chemotherapy, radiation, or drugs.
- Individuals who have had a partial or total hysterectomy.
- Use of any treatment for menopausal symptoms or other concomitant treatments listed under the "concomitant therapies" section of the protocol
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
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-HF 3.0Take 2 capsules once daily in the mornings with food | Dietary supplement | Test Product: JDS-HF3.0 Capsules |
| PlaceboTake 2 capsules once daily in the mornings with food | Dietary supplement | Placebo Capsules |
Primary outcome
To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS).
Time frame: 12 weeks
Change from baseline for the number and severity of hot flashes measured by HFRDIS scores. The HFRDIS has a scoring range of 0-100, with higher values indicating worse symptoms.
4 secondary outcomes
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Greene Climacteric Scale (GCS).
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Menopausal Rating Scale (MRS).
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: 12 weeks
To determine the effect of the TP compared to the placebo on quality of life as determined by the Menopause-Specific Quality of Life (MENQOL) questionnaire.
Time frame: 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 26 Jun 2024.
- Derived from this study: PubMed 42284819Lederman S, Minkin MJ, Doyle AL, Rubio J, Recker S, Lin LX, VanDusseldorp T. Neurokinin pathway botanical antagonist for menopausal vasomotor symptoms: A randomized, double-blind, placebo-controlled study. Maturitas. 2026 Aug;211:109023. doi: 10.1016/j.maturitas.2026.109023. Epub 2026 Jun 10.
- Individual participant dataSharing planned: No
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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.
Samuel N Lederman, MD principal investigator
Altus Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JDS-HF 3.0 in people with Vasomotor Symptoms and Postmenopausal Disorders, run by Bonafide Health at 3 sites 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 10 inclusion and 21 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
To determine the effects of the Test Product (TP) compared to placebo on hot flash symptoms as determined by the Hot Flash Related Daily Interference Scale (HFRDIS). (time frame: 12 weeks). 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 NCT05813067, which also lists 1 linked publication.
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 26 Jun 2024.