Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shatavari Root Extract, oral capsule.
- Who it may be relevant to
- Registry conditions: D008593. Basic parameters: 40 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial
Overview
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
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)
Primary outcome measures
- Composite hot flash score: Frequency × Severity [Time frame: 30 days]
Secondary outcome measures (1)
- Menopause Rating Scale [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Jacksonville University — Jacksonville
Identifiers
NCT: NCT06939868 · SterlingIRB2025