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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: D008593
• Intervention / Treatment: Dietary supplement: Shatavari Root Extract, oral capsule

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather A Hausenblas, PhD; Phone Number: 904-891-9746; Email: hhausen@ju.edu
• Study Contact Backup: Name: Stephanie L Hooper, MPH; Phone Number: 908-868-8740; Email: s.hooper@unf.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32211
      • Jacksonville University
      • Contact: Heather A Hausenblas, PhD; Phone Number: 904-891-9746; Email: hhausen@ju.edu
      • Contact: Stephanie L Hooper, MPH; Phone Number: 908-868-8740; Email: s.hooper@unf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supplement Group	Dietary supplement: Shatavari Root Extract, oral capsule; 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.
Placebo Comparator: Placebo Group: Sugar pill	Dietary supplement: Shatavari Root Extract, oral capsule; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite hot flash score: Frequency × Severity	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)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause Rating Scale	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.	30 days

Collaborators and Investigators

• Sponsor: Jacksonville University
• Investigators: Principal Investigator: Heather A Hausenblas, PhD, Jacksonville University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: menopause; supplement; hot flashes
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: SterlingIRB2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No