D008593NCT06939868
Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women
A study testing Shatavari Root Extract, oral capsule in people with D008593, run by Jacksonville University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- D008593
- What is being tested?
- Shatavari Root Extract, oral capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Current use of hormone therapy or other medications known to affect hot flashes.
- Significant comorbidities that may interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Jacksonville University
Jacksonville, Florida, 32211
Heather A Hausenblas, PhD, 904-891-9746, hhausen@ju.edu
Stephanie L Hooper, MPH, 908-868-8740, s.hooper@unf.edu
About this study
Official title: Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial
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:
Read more
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.
Read the 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
- Being tested
- Shatavari Root Extract, oral capsule
- Keywords
- menopause, hot flashes, supplement
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shatavari Root Extract, oral capsuleDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Supplement Group | Active comparator | Not described Receives: Dietary Supplement: Shatavari Root Extract, oral capsule |
| Placebo Group: Sugar pill | Placebo comparator | Not described Receives: Dietary Supplement: Shatavari Root Extract, oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (1)
Menopause Rating Scale
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D008593Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacksonville University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather A Hausenblas, PhD, Principal investigator, Jacksonville University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939868
- Sponsor's protocol ID
- SterlingIRB2025
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06939868
- Acronym / sponsor ID
- SterlingIRB2025
- Conditions
- D008593
- Keywords
- menopause, hot flashes, supplement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Jacksonville UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Active comparator | Dietary Supplement: Shatavari Root Extract, oral capsule |
| Placebo Group: Sugar pill | Placebo comparator | Dietary Supplement: Shatavari Root Extract, oral capsule |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Current use of hormone therapy or other medications known to affect hot flashes.
- Significant comorbidities that may interfere with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shatavari Root Extract, oral capsuleThis 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. | Dietary supplement | Placebo Group: Sugar pill, Supplement Group |
Primary outcome
Composite hot flash score: Frequency × Severity
Time frame: 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)
1 secondary outcome
Menopause Rating Scale
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather A Hausenblas, PhD principal investigator
Jacksonville University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shatavari Root Extract, oral capsule in people with D008593, run by Jacksonville University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather A Hausenblas, PhD (904-891-9746, hhausen@ju.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite hot flash score: Frequency × Severity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.