JDS-HF3.0 for Menopause Symptoms

Overseen By Trisha VanDusseldorp, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Bonafide Health

Must not be taking: Glucosamine, Chondroitin, Curcumin, others

Disqualifiers: Pregnancy, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new supplement, JDS-HF3.0, can reduce menopause symptoms such as joint discomfort, hot flashes, and night sweats. Participants will take either the supplement or a placebo daily for 12 weeks to assess symptom improvement. Women who have been postmenopausal for at least a year and experience moderate to severe joint discomfort and frequent hot flashes may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance menopause symptom management.

Is there any evidence suggesting that JDS-HF3.0 is likely to be safe for humans?

Research is examining the safety and effectiveness of JDS-HF3.0 for treating menopause symptoms like hot flashes and night sweats. Unfortunately, previous studies provide limited detailed safety information. This trial is labeled "Not Applicable" in terms of phase, indicating it is either an early-stage study or does not fit into the usual phase categories.

The limited safety data suggests there might not be much evidence from past human trials on how well people tolerate JDS-HF3.0. However, its current testing in humans implies that researchers have some initial evidence suggesting it is safe enough for further study. Participants should consult the study team to learn more about any known risks or side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for menopause symptoms?

Unlike the standard treatments for menopause symptoms, which often include hormone replacement therapy or SSRIs, JDS-HF3.0 stands out because it is a non-hormonal supplement. Researchers are excited about JDS-HF3.0 because it specifically targets the underlying biochemical pathways associated with menopause symptoms without altering hormone levels. This innovative approach could provide a safer alternative for those who cannot use hormone-based therapies. Additionally, the potential for fewer side effects makes it an attractive option for a broader range of women experiencing menopause.

What evidence suggests that JDS-HF3.0 might be an effective treatment for menopause symptoms?

Research shows that JDS-HF3.0 might help reduce menopause symptoms like hot flashes and night sweats. Some studies have explored its impact on women's quality of life during menopause. Early results suggest that taking JDS-HF3.0 could make these symptoms less severe and less frequent. Although detailed information remains limited, the supplement is believed to help with these common menopause symptoms. This trial will compare the effects of JDS-HF3.0 with a placebo to evaluate its potential benefits, potentially offering relief for many experiencing discomfort during this stage of life. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 50-70 who are experiencing common menopause symptoms like joint pain, arthritis, hot flashes, and night sweats. The study aims to see if the participants' quality of life can be improved over a period of 12 weeks.

Inclusion Criteria

Body mass index (BMI) between 18.5 to 34.9 kg/m2

In good general health and able to consume the study product

Have reliable access to Wi-Fi and a smart phone/device

Exclusion Criteria

History of alcohol or substance abuse in the last 5 years

Lactating, pregnant, or planning pregnancy during the study

Active participation in another clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Baseline

Collection of baseline values before starting the treatment

1 week

1 visit (virtual)

Treatment

Participants receive either the active study product or placebo for 12 weeks

12 weeks

2 check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• JDS-HF3.0

Trial Overview The trial is testing JDS-HF3.0 supplementation against a placebo to determine its effectiveness in reducing the severity and frequency of menopause-related symptoms such as joint discomfort, hot flashes, and night sweats.

How Is the Trial Designed?

Group I: JDS-HF3.0 Active Group Active Control 1 Intervention

Group of participants supplementing with JDS-HF3.0

Group II: Placebo Comparator Placebo Group 1 Intervention

Group consuming nonactive placebo

Who Is Running the Clinical Trial?

Bonafide Health

Lead Sponsor

Trials

2

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07238478?aggFilters=status%3A

JDS-HF3.0 Supplementation on Menopause Related ... The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause ...

2. trialstoday.org trialstoday.org/trial/NCT07238478

JDS-HF3.0 Supplementation on Menopause Related ... The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05813067

Study Details | NCT05813067 | Herbal Nutraceutical ... The goal of this study is to evaluate a dietary supplement for its safety and effects on vasomotor symptoms in menopausal women.

4. trial.medpath.com trial.medpath.com/clinical-trial/dbc8142ccaf587a2/nct05813067-effects-jds-hf3-vasomotor-symptoms-menopausal-women

Herbal Nutraceutical Supplementation on Vasomotor ... Menopausal women often experience changes in vaginal health and sexuality, loss of bladder control, changes in mood, decreased sleep quality, changes in body ...

5. meddatax.com meddatax.com/clinical-trials/NCT05813067

Herbal Nutraceutical Supplementation on Vasomotor Symptoms in ... The study team has not published outcome measurements, participant flow, or safety data for this trial yet. ... Test Product: JDS-HF3.0 Capsules. Dietary ...

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations

FDA Requests Labeling Changes Related to Safety ... MHTs are used to provide relief from common menopause symptoms, such as hot flashes and night sweats (also known as vasomotor symptoms (VMS)) ...

7. trial.medpath.com trial.medpath.com/clinical-trial/c9891318a6929016/nct07238478-jds-hf3-menopause-quality-life-postmenopausal-women

JDS-HF3.0 Supplementation on Menopause Related Quality ... The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause ...

8. theconversation.com theconversation.com/i-treat-menopause-and-its-symptoms-and-hormone-replacement-therapy-can-help-heres-the-science-behind-the-fdas-decision-to-remove-warnings-269773

I treat menopause and its symptoms, and hormone ... I treat menopause and its symptoms, and hormone replacement therapy can help – here's the science behind the FDA's decision to remove warnings.