Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women

Not Applicable

Not yet recruiting

• Conditions: D008593

• Registration Number: NCT06939868
• Lead Sponsor: Jacksonville University

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.

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

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Study Start: 2025-05-01
• Primary Completion: 2025-08-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Adult women aged 40-60 years.
• Menopause Rating Scale score: (a) GE 14 and (b) score of 3 or 4 (severe to very severe) for hot flashes (Blumel et al., 2018).

Exclusion Criteria

• Current use of hormone therapy or other medications known to affect hot flashes.
• Significant comorbidities that may interfere with study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite hot flash score: Frequency × Severity	30 days	Frequency: Total number of hot flashes experienced that day. Hot Flash Severity: Rating of hot flashes on a 7-point severity scale (0 = none, 1 = very mild, 2 = mild, 3 = mild/moderate, 4 = moderate, 5 = severe, 6 = very severe)

Secondary Outcome Measures

Name	Time	Method
Menopause Rating Scale	30 days	Validated self-administered questionnaire consisting of 11 items that assesses menopausal symptoms. Each item is rated on a 5-point Likert scale from 0 (not present) to 4 (very severe), yielding a total score range of 0 to 44, with higher scores indicating more severe symptoms. The Menopause Rating Scale is divided into three domains: somatic (hot flashes, heart discomfort, sleep problems, joint and muscular discomfort), psychological (depressive mood, irritability, anxiety, physical and mental exhaustion), and urogenital (sexual problems, bladder problems, vaginal dryness). This scale has been widely used in clinical research to quantify menopausal symptom burden and its impact on quality of life.

Trial Locations

Locations (1)

Jacksonville University; 🇺🇸 Jacksonville, Florida, United States