Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813067
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2023-03-28
Brief Title:
Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women
Sponsor:
Bonafide Health
Organization:
Bonafide Health
Study Overview
Official Title:
The Effects of JDS-HF30 on Vasomotor Symptoms in Menopausal Women A Randomized Double-Blinded Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Menopause is characterized by the cessation of menstruation for 12 consecutive months It is a natural phase in which a womens 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None