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Study to Investigate Asparagus Racemosus Extract (Shaktiva™) for Psychological Symptoms in Perimenopausal Women
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
- Sponsor
- Liaquat University of Medical & Health Sciences (Academic or other)
- Enrolment
- 100 planned
- Conditions
- Perimenopausal Disorder
- Interventions
- Asparagus racemosus Extract (Shaktiva™); Placebo
- Ages
- adults
- Registry
- NCT07853560
From the registry
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.
Primary outcomes
- Change in DASS-42 Depression Subscales Scores