NCT06939868

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Jacksonville University · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-08-30
• Completion: 2025-09-30
• First posted: 2025-04-23
• Last updated: 2025-04-23

Locations

1 site across 1 country: United States