The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial

NCT07210229 | Not Yet Recruiting

• 1 other identifier: 25-08-200
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as compared to a placebo.

Conditions

Menopausal Hot Flashes; Menopausal Women

Keywords

ashwagandha

Outcome Measures

Primary Outcomes (3)

• Proprietary Menopause Symptom Scale (NRI-MSS)

  Nutraceuticals Research Institute's Menopause Symptom Scale is a validated self-report scale measuring symptoms across 6 domains. Scores range from 0-30, with higher scores indicating greater symptom severity.

  days 0, 28, 56, and 84

• Menopause-Specific Quality of Life (MenQoL)

  The MenQoL evaluates quality of life among menopausal women. Scores range from 0-8 with higher scores indicating greater symptom severity.

  days 0, 28, 56, and 84

• Menopause Rating Scale (MRS)

  The MRS is a self report assessment of menopausal symptoms with scores ranging from 0-44. Higher scores indicate greater symptom severity.

  Days 0, 28, 56, and 84

Secondary Outcomes (2)

• Estriol

  days 0, 84

• Estradiol

  days 0, 84

Study Arms (3)

Plant Extract 1

EXPERIMENTAL

Participants in this arm will take an ashwagandha root supplement each day for 84 days.

Dietary Supplement: ashwagandha root

Plant Extract 2

EXPERIMENTAL

Participants in this arm will take an ashwagandha root and leaf supplement each day for 84 days.

Dietary Supplement: ashwagandha root and leaf

Placebo

PLACEBO COMPARATOR

Participants in this arm will take an inert placebo each day for 84 days.

Other: Placebo

Interventions

ashwagandha root DIETARY_SUPPLEMENT

This substance is extracted from the root of the plant.

Plant Extract 1

ashwagandha root and leaf DIETARY_SUPPLEMENT

This substance is extracted from both the root and leaves of the plant.

Plant Extract 2

Placebo OTHER

The inert placebo does not contain any of the plant matter.

Placebo

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: Biological sex of woman, gender identity of female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
• Baseline score of above-average menopause symptom levels on each of the patient reported scales: NRI-MSS (defined as 22+), the MRS scale (defined as 9+), AND 4+ on the MENQoL.
• Confirmation of presence of hot flashes
• Estridiol levels within the bottom 35% of normal ranges for their menstrual cycle phase (follicular/ovulation/luteal) as established by laboratory reference range
• Biological sex of female; gender identification of woman
• Aged 40 to 55, inclusive
• Good general health as evidenced by medical history and screening
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
• Still menstruating regularly (defined at least one period every 60 days)
• Agreement to adhere to Lifestyle Considerations throughout study duration

You may not qualify if:

• Pregnant, trying to conceive, or breastfeeding
• Hysterectomy, uterine ablation, or related procedure
• Amenorrhea
• Consumes \> 8 alcoholic beverages in an average week
• Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
• Consumes any hormonal therapies or menopause-related supplements intended to improve symptoms in any way
• Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants
• Any liver, kidney, hormonal, or cardiovascular disorder
• Known allergic reactions to any components of the intervention
• Recent dramatic weight changes (10% change in body weight in the last 6 months)
• Introducing a new investigational drug or other intervention within 60 days before the start of the study
• Any change to diet or lifestyle within 60 days before the start of the study (defined as introducing any new exercise activity, joining a gym, starting a new routine, moving to a new home, adjusting dietary habits (e.g. vegetarian, paleo, etc) or discontinuing any habits or diets.
• Any health or medical condition which, in the primary investigators opinion, may interfere with the conduct of the study

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessie Cavanaugh, PhD

CONTACT

256-203-9010; j.cavanaugh@nutraceuticalsresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 30, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)