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NCT07853560

Study to Investigate Asparagus Racemosus Extract (Shaktiva™) for Psychological Symptoms in Perimenopausal Women

Sponsor: Liaquat University of Medical & Health Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of a Standardised Extract of Asparagus Racemosus (Shaktiva™) on Psychological and Physical Symptoms in Perimenopausal Women: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

FEMALE

Age Range

40 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-12-01

Completion Date

2027-03-31

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Perimenopausal Disorder

Interventions

DIETARY_SUPPLEMENT

Asparagus racemosus Extract (Shaktiva™)

A standardised Asparagus racemosus (Shatavari) extract administered orally at a dose of 300 mg once daily for 8 weeks.

OTHER

Placebo

A matching placebo designed to be identical, as far as practicable, to the active intervention in appearance, size, colour, taste, packaging, and administration schedule.

Inclusion Criteria: Participants must meet all of the following: * 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. * Willing to maintain their usual diet and lifestyle throughout the study. * Willing to refrain from starting other supplements intended for menopausal symptoms, mood, anxiety, stress, or sleep during the study. * Able and willing to provide written informed consent. Exclusion Criteria: Participants will be excluded if any of the following apply: * 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. * Current regular use of prescription or over-the-counter sleep medication/hypnotics likely to influence sleep outcomes. * Use of herbal or dietary supplements specifically intended to treat menopausal symptoms, mood, anxiety, stress, or sleep within the 4 weeks before screening. * History of bilateral oophorectomy or surgical menopause. * Clinically significant psychiatric disorder requiring active specialist psychiatric management. * Current severe major depressive episode, clinically significant suicidal ideation, or other psychiatric condition requiring immediate clinical intervention. * Clinically significant uncontrolled endocrine disease, including uncontrolled thyroid disease. * Significant hepatic, renal, cardiovascular, neurological, or other systemic disease that, in the investigator's judgment, may affect participant safety or interpretation of the study results. * Current or recent alcohol or substance abuse. * Known hypersensitivity to any constituent of the investigational product or placebo. * Participation in another clinical intervention study within the preceding 3 months. * Pregnancy, breastfeeding, or intention to become pregnant during the study. * Any other condition considered by the investigator to make participation unsafe or interfere with protocol compliance.