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

NCT06939868 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

  • D008593

Interventions

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.

Sponsors & Collaborators

  • Jacksonville University

    lead OTHER

Principal Investigators

  • Heather A Hausenblas, PhD · Jacksonville University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-08-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939868 on ClinicalTrials.gov