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NCT Number: NCT06939868

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

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.

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Key information

Conditions

D008593 Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shatavari Root Extract, oral capsule

Dietary Supplement

This intervention consists of a proprietary, standardized extract of Asparagus racemosus (Shatavari), formulated specifically for women's health and cognitive support. The supplement is provided in oral capsule form and standardized to a specific concentration of shatavarin IV, the primary active compound. Participants will take one capsule daily for 30 days.

This formulation, known as SheVari4™, is patent-pending and manufactured by Cepham, designed to address vasomotor symptoms (hot flashes) and other menopausal concerns. It is distinct from other Shatavari supplements in its standardization and use in a placebo-controlled, double-blind trial targeting postmenopausal women.

Primary outcomes

  1. Composite hot flash score: Frequency × Severity

    Time frame: 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 outcomes

  1. Menopause Rating Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather A Hausenblas, PhD

CONTACT

[email protected]

904-891-9746

Stephanie L Hooper, MPH

CONTACT

[email protected]

908-868-8740

Sponsors and collaborators

Lead sponsor

Jacksonville University

Other

Registry information

Official study title

Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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