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Herbal Nutraceutical
Test Product: JDS-HF3.0 Capsules for Hot Flashes
N/A
Waitlist Available
Led By Samuel N Lederman, MD
Research Sponsored by Bonafide Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing a dietary supplement made from plant ingredients to help menopausal women who have hot flashes and night sweats. The supplement aims to improve their sleep and mood by reducing these symptoms.
Eligible Conditions
- Hot Flashes
- Postmenopausal Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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).
Secondary study objectives
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.
+1 moreOther study objectives
To assess the safety and tolerability of the TP compared to the placebo in healthy participants.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test Product: JDS-HF3.0 CapsulesExperimental Treatment1 Intervention
Dietary supplement containing a proprietary botanical blend with NK3R antagonistic activity
Group II: Placebo CapsulesPlacebo Group1 Intervention
Placebo capsule containing:
* Microcrystalline cellulose
* Silicon dioxide micronized
* Magnesium stearate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JDS-HF 3.0
2022
N/A
~80
Find a Location
Who is running the clinical trial?
Bonafide HealthLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
36 Previous Clinical Trials
2,040 Total Patients Enrolled
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have participated in another research study and received a test product within the last 28 days or longer if the previous test product could affect your eligibility or outcomes in this study.You have smoked within the past 3 years.Your BMI is between 18.5 and 34.9 kg/m2, inclusive.You are compliant with the parameters of this study, have given consent willingly, can comprehend and read all survey materials, and are capable of executing associated research activities.You have an MRS score of 2 or more at screening and baseline.You have experienced menopausal symptoms in the last 6 months.You experience an average of five or more moderate to severe hot flashes and night sweats on a daily basis for 7 days.You are a healthy menopausal woman aged between 40 and 65.You have had a menstrual period at least 6 months before the screening.You possess normal or investigator-approved vital signs (blood pressure and heart rate) at the screening stage.You must abstain from treatments for hot flashes and other menopausal symptoms.You cannot use any vaginal medications, sprays, patches or cooling devices designed to manage hot flashes one week before and during the study.You have been vaccinated for COVID-19 within the past two weeks or have a current COVID-19 infection. You also cannot have ongoing symptoms related to COVID-19 that have lasted for at least two months and cannot be explained by another medical condition.You had surgery to treat obesity in the past.You are allergic to any of the study products or their ingredients.You possess sound health and are able to ingest the study product.You experienced menopause due to surgery, chemotherapy, radiation or medication.You have a history of drinking too much alcohol or using drugs.You are currently taking medication for menopausal symptoms or any other treatments listed in the study protocol.You have a history or current condition affecting your digestive system, liver, or kidneys that may prevent proper absorption, processing, or excretion of drugs.You have a history of heart, kidney or liver disease, or currently have an ongoing infection such as lyme disease, tuberculosis or HIV.You have had cancer (except for skin cancer that has not spread) in the last five years. Women who have had breast cancer, currently or in the past, will not be included.
Research Study Groups:
This trial has the following groups:- Group 1: Test Product: JDS-HF3.0 Capsules
- Group 2: Placebo Capsules
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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