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

NCT ID: NCT06939868

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-09-30

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

Conditions

D008593

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Supplement Group

Group Type: ACTIVE_COMPARATOR

Shatavari Root Extract, oral capsule

Intervention Type: 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.

Placebo Group: Sugar pill

Group Type: PLACEBO_COMPARATOR

Shatavari Root Extract, oral capsule

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jacksonville University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather A Hausenblas, PhD

Role: PRINCIPAL_INVESTIGATOR

Jacksonville University

Locations

Jacksonville University

Jacksonville, Florida, United States

Countries

United States

Central Contacts

Heather A Hausenblas, PhD

Role: CONTACT

hhausen@ju.edu

904-891-9746

Stephanie L Hooper, MPH

Role: CONTACT

s.hooper@unf.edu

908-868-8740

Facility Contacts

Heather A Hausenblas, PhD

Role: primary

hhausen@ju.edu

904-891-9746

Stephanie L Hooper, MPH

Role: backup

s.hooper@unf.edu

908-868-8740

Other Identifiers

SterlingIRB2025

Identifier Type: -

Identifier Source: org_study_id