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

Jacksonville University

Status

Not yet enrolling

Conditions

D008593

Treatments

Dietary Supplement: Shatavari Root Extract, oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT06939868

SterlingIRB2025

Details and patient eligibility

About

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.

Full 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

Enrollment

44 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.