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

Nutraceuticals Research Institute

Status: Not yet enrolling

Conditions: Menopausal Women; Menopausal Hot Flashes

Treatments: Other: Placebo; Dietary Supplement: ashwagandha root; Dietary Supplement: ashwagandha root and leaf

Study type: Interventional

Funder types: Other

Identifiers

NCT07210229

25-08-200

Details and patient eligibility

About

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.

Full description

Participants will take one of two extracts or a placebo every day for 84 days; outcomes of self-report menopausal symptoms collected on a trio of scales will provide information on effectiveness.

Enrollment: 90 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Plant Extract 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: ashwagandha root

Plant Extract 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: ashwagandha root and leaf

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo