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

NCT06939868 | Not Yet Recruiting

• 1 other identifier: SterlingIRB2025
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

D008593

Keywords

menopause; hot flashes; supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Menopause Rating Scale

  30 days

Study Arms (2)

Supplement Group

ACTIVE COMPARATOR

Dietary Supplement: Shatavari Root Extract, oral capsule

Placebo Group: Sugar pill

PLACEBO COMPARATOR

Dietary Supplement: Shatavari Root Extract, oral capsule

Interventions

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.

Placebo Group: Sugar pill; Supplement Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Current use of hormone therapy or other medications known to affect hot flashes.
• Significant comorbidities that may interfere with study participation.

Sponsors & Collaborators

• Jacksonville University: lead

Study Sites (1)

Jacksonville University

Jacksonville, Florida, 32211, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heather A Hausenblas, PhD

  Jacksonville University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather A Hausenblas, PhD

CONTACT

904-891-9746; hhausen@ju.edu

Stephanie L Hooper, MPH

CONTACT

908-868-8740; s.hooper@unf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 23, 2025
• Study Start: May 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)