Perimenopause is commonly associated with psychological symptoms, including low mood, anxiety, and stress, which can negatively affect wellbeing and quality of life. This study will investigate whether Shaktiva™, a standardised extract of Asparagus racemosus (Shatavari), can improve psychological symptoms in perimenopausal women.
This is an 8-week, multicentre, randomized, double-blind, placebo-controlled clinical trial involving 100 perimenopausal women. Participants will be randomly assigned to receive either Shaktiva™ 300 mg once daily or a matching placebo. The study will primarily evaluate changes in depression, anxiety, and stress. It will also assess mood and affect, mental wellbeing, menopausal symptoms, sleep, quality of life, safety, and selected hormones.
Female participants aged 40-55 years.
Meet STRAW+10 criteria for early (Stage -2) or late (Stage -1) menopausal transition, defined as either a persistent change in menstrual-cycle length of ≥7 days during the preceding 12 months or an interval of amenorrhoea of ≥60 days but <12 months.
Have experienced at least one menstrual period within the preceding 12 months.
Mild-to-moderate symptoms in at least two of the three DASS-42 domains (Depression, Anxiety, and Stress) at screening, according to predefined DASS-42 severity thresholds.
Postmenopausal status, defined as ≥12 consecutive months of amenorrhoea.
Current use of menopausal hormone therapy (HRT/MHT) or other hormonal therapy likely to influence menopausal symptoms or study hormone measurements.
Current use of antidepressant medication.
Current regular use of anxiolytic or other psychotropic medication likely to materially influence mood, anxiety, or stress outcomes.
Parallel
Asparagus racemosus Extract (Shaktiva™)
Dietary supplementA standardised Asparagus racemosus (Shatavari) extract administered orally at a dose of 300 mg once daily for 8 weeks.
Placebo
Other interventionA matching placebo designed to be identical, as far as practicable, to the active intervention in appearance, size, colour, taste, packaging, and administration schedule.
Change in DASS-42 Depression Subscales Scores
Change from baseline in the Depression subscale score of the 42-item Depression Anxiety Stress Scales (DASS-42). The Depression subscale consists of 14 items rated from 0 to 3, giving a score ranging from 0 to 42. Higher scores indicate greater severity of depressive symptoms.
Change in Positive and Negative Affect Schedule (PANAS) Scores
Change from baseline in Positive Affect and Negative Affect scores measured using the Positive and Negative Affect Schedule (PANAS). PANAS consists of two 10-item subscales measuring Positive Affect and Negative Affect. Each subscale ranges from 10 to 50, with higher scores indicating greater positive or negative affect, respectively.
Change in Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) Total Score
Change from baseline in mental wellbeing measured using the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). Each item is rated on a 5-point scale, giving a total score ranging from 14 to 70. Higher scores indicate greater mental wellbeing.
Change in Menopause Rating Scale (MRS) Scores
Change from baseline in menopausal symptoms measured using the 11-item Menopause Rating Scale (MRS). The MRS provides a total score ranging from 0 to 44 and scores for the psychological, somato-vegetative, and urogenital domains. Higher scores indicate greater menopausal symptom severity.
Change in Regensburg Insomnia Scale (RIS) Total Score
Change from baseline in insomnia symptoms measured using the 10-item Regensburg Insomnia Scale (RIS). The total score ranges from 0 to 40, with higher scores indicating greater insomnia severity.
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