D008593
Conditions
Keywords
menopause, hot flashes, supplement
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.
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_SUPPLEMENTShatavari 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
Jacksonville University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite hot flash score: Frequency × Severity | 30 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Rating Scale | 30 days | Validated self-administered questionnaire consisting of 11 items that assesses menopausal symptoms. Each item is rated on a 5-point Likert scale from 0 (not present) to 4 (very severe), yielding a total score range of 0 to 44, with higher scores indicating more severe symptoms. The Menopause Rating Scale is divided into three domains: somatic (hot flashes, heart discomfort, sleep problems, joint and muscular discomfort), psychological (depressive mood, irritability, anxiety, physical and mental exhaustion), and urogenital (sexual problems, bladder problems, vaginal dryness). This scale has been widely used in clinical research to quantify menopausal symptom burden and its impact on quality of life. |
Countries
United States
Contacts
Primary ContactHeather A Hausenblas, PhD
Backup ContactStephanie L Hooper, MPH
Outcome results
None listed