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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorNutraceuticals Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant, trying to conceive, or breastfeeding

Hysterectomy, uterine ablation, or related procedure

Amenorrhea

Consumes > 8 alcoholic beverages in an average week

Trial design

Treatments tested in this trial

  • ashwagandha root
  • ashwagandha root and leaf
  • Placebo

Treatment groups

90 Participants
are divided into 3 treatment groups