Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Jacksonville University
- Study ID
- NCT06939868
- Status
- Not Yet Recruiting
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Conditions
- D008593
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Shatavari Root Extract, oral capsule — DIETARY_SUPPLEMENTThis 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.
Study Details
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.
Key Dates
- Start date
- May 1, 2025
- Status verified
- Apr 2025
- Primary completion
- Aug 30, 2025
- Completion
- Sep 30, 2025
Study Design
- Enrollment
- 44 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Supplement Group
- Placebo Comparator: Placebo Group: Sugar pill
Primary Outcome Measure
Composite hot flash score: Frequency × Severity [ Time Frame: 30 days ]
Central Contacts
- Heather A Hausenblas, PhD904-891-9746
- Stephanie L Hooper, MPH908-868-8740
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Jacksonville University | Jacksonville | Florida | 32211 |