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Not Yet Recruiting NCT07853560

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

Conditions: Perimenopausal Disorder

Sex: Female
Ages: 40 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Liaquat University of Medical & Health Sciences

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.

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07853560). StuddyBuddy aggregates publicly available trial information.