Test Product: JDS-HF3.0 Capsules for Hot Flashes

Altus Research, Lake Worth, FL
Hot Flashes+1 More ConditionsJDS-HF 3.0 - DietarySupplement
Eligibility
40 - 65
Female
What conditions do you have?
Select

Study Summary

This trial looks at a dietary supplement to see if it safely reduces hot flashes in menopausal women.

Eligible Conditions
  • Hot Flashes
  • Postmenopausal Disorders

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Pilot Trial: Osanetant 28 Days
1
ACER-801 50 mg BID
1
FP-101

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 weeks

12 weeks
To assess the safety and tolerability of the TP compared to the placebo in healthy participants.
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Greene Climacteric Scale (GCS).
To determine the effect of the TP compared to the placebo on overall menopausal symptoms as determined by the Menopausal Rating Scale (MRS).
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.
To determine the effect of the TP compared to the placebo on sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI).
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).

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Pilot Trial: Osanetant 28 Days
1
ACER-801 50 mg BID
2
FP-101

Trial Design

2 Treatment Groups

Test Product: JDS-HF3.0 Capsules
1 of 2
Placebo Capsules
1 of 2

Experimental Treatment

Non-Treatment Group

64 Total Participants · 2 Treatment Groups

Primary Treatment: Test Product: JDS-HF3.0 Capsules · Has Placebo Group · N/A

Test Product: JDS-HF3.0 Capsules
DietarySupplement
Experimental Group · 1 Intervention: JDS-HF 3.0 · Intervention Types: DietarySupplement
Placebo Capsules
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
29 Previous Clinical Trials
1,629 Total Patients Enrolled
Bonafide HealthLead Sponsor
Samuel N Lederman, MDPrincipal InvestigatorAltus Research
1 Previous Clinical Trials
570 Total Patients Enrolled
1 Trials studying Hot Flashes
570 Patients Enrolled for Hot Flashes

Eligibility Criteria

Age 40 - 65 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You experience an average of five or more moderate to severe hot flashes and night sweats on a daily basis for 7 days.
Your BMI is between 18.5 and 34.9 kg/m2, inclusive.
You have an MRS score of 2 or more at screening and baseline.
You have experienced menopausal symptoms in the last 6 months.
You must abstain from treatments for hot flashes and other menopausal symptoms.
References

Frequently Asked Questions

Is this study open to adolescents below the age of twenty?

"Participants must be between 40 and 65 years of age to meet the qualifications for this trial." - Anonymous Online Contributor

Unverified Answer

Are there any requirements that preclude me from entering this trial?

"Recruitment for this trial is targeting 64 individuals between the ages of 40 and 65, who are suffering from hot flashes." - Anonymous Online Contributor

Unverified Answer

Is there still availability for individuals to join this clinical experiment?

"Indeed, clinicaltrials.gov displays that this medical trial is still open for recruitment and was first posted on May 1st 2023 with its latest update occurring on April 12th, 2023. The study is in need of 64 participants from 2 distinct sites." - Anonymous Online Contributor

Unverified Answer

To what extent is the enrollment for this trial open?

"Affirmative. The clinicaltrials.gov portal confirms that this research project, which was initially announced on May 1st 2023, is currently recruiting participants. Specifically, the team needs 64 individuals from 2 distinct medical institutions." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top