Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 8:17 AM
Study NCT ID:
NCT06939868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women
Sponsor:
Jacksonville University
Organization:
Study Overview
Official Title:
Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
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 goal of this clinical trial is to learn if a daily nutritional supplement can reduce hot flashes and other menopausal symptoms in postmenopausal women.
The main questions this study aims to answer are:
Does the supplement reduce the number and severity of daily hot flashes?
Does it improve other common menopausal symptoms?
Researchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause.
Participants will:
Take either the supplement or a placebo daily for 30 days
Track their hot flashes each day using a short online survey
Complete a symptom questionnaire at the beginning and end of the study
This study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.
The main questions this study aims to answer are:
Does the supplement reduce the number and severity of daily hot flashes?
Does it improve other common menopausal symptoms?
Researchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause.
Participants will:
Take either the supplement or a placebo daily for 30 days
Track their hot flashes each day using a short online survey
Complete a symptom questionnaire at the beginning and end of the study
This study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.
Detailed Description:
Purpose:
To evaluate the effectiveness of a nutritional supplement in reducing hot flash severity/frequency and menopausal symptoms in postmenopausal women.
Design:
Randomized, double-blind, placebo-controlled, two-arm, parallel-group trial over 30 days.
Participants:
Women aged 40-60 who are postmenopausal (≥1 year without menses) and report bothersome hot flashes (Menopause Rating Scale score ≥14, and hot flash severity of 3 or 4).
Exclusion Criteria:
Current hormone therapy or medications affecting hot flashes; significant comorbidities.
Intervention:
Group 1: Placebo
Group 2: Supplement
Assessments:
Daily self-reports of hot flash frequency/severity
Menopausal symptom assessments at baseline (Day 0) and post-intervention (Day 30)
Outcomes:
Primary: Hot flash severity and frequency
Secondary: Overall menopausal symptoms
To evaluate the effectiveness of a nutritional supplement in reducing hot flash severity/frequency and menopausal symptoms in postmenopausal women.
Design:
Randomized, double-blind, placebo-controlled, two-arm, parallel-group trial over 30 days.
Participants:
Women aged 40-60 who are postmenopausal (≥1 year without menses) and report bothersome hot flashes (Menopause Rating Scale score ≥14, and hot flash severity of 3 or 4).
Exclusion Criteria:
Current hormone therapy or medications affecting hot flashes; significant comorbidities.
Intervention:
Group 1: Placebo
Group 2: Supplement
Assessments:
Daily self-reports of hot flash frequency/severity
Menopausal symptom assessments at baseline (Day 0) and post-intervention (Day 30)
Outcomes:
Primary: Hot flash severity and frequency
Secondary: Overall menopausal symptoms
Study Oversight
Has Oversight DMC:
False
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?: