Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT06939868
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:
NCT06939868
Study Brief:
Protocol Section:
NCT06939868