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

NCT07853560 | Not Yet Recruiting DMC

• 1 other identifier: LUMHS/REC/Temp/26.09.2026
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perimenopausal Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4 and Week 8

Secondary Outcomes (9)

• Change in Positive and Negative Affect Schedule (PANAS) Scores

  Baseline to Week 4 and Week 8

• Change in Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) Total Score

  Baseline to Week 4 and Week 8

• Change in Menopause Rating Scale (MRS) Scores

  Baseline to Week 4 and Week 8

• Change in Regensburg Insomnia Scale (RIS) Total Score

  Baseline to Week 4 and Week 8

• Change in SF-36 Health-Related Quality of Life Scores

  Baseline to Week 4 and Week 8

Study Arms (2)

Asparagus racemosus extract supplement (Shaktiva™)

EXPERIMENTAL

Participants will receive Shaktiva™ (Asparagus racemosus extract) 300 mg orally once daily for 8 weeks.

Dietary Supplement: Asparagus racemosus Extract (Shaktiva™)

Placebo

PLACEBO COMPARATOR

Participants will receive one matching placebo tablet orally once daily for 8 weeks. The placebo will be matched to the active intervention, as far as practicable, in appearance, size, colour, taste, packaging, and administration schedule.

Other: Placebo

Interventions

Asparagus racemosus Extract (Shaktiva™) DIETARY_SUPPLEMENT

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

Asparagus racemosus extract supplement (Shaktiva™)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Central Study Contacts

Dr Amjad Khan, DPhil

CONTACT

03000506955; amjadkhan@lumhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, study coordinators, outcome assessors, and the primary statistical team will remain blinded to treatment allocation until the database has been finalized and locked, except where emergency unblinding is medically necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Participants will be randomized in a 1:1 ratio to receive either Shaktiva™ 300 mg/day or matching placebo for 8 weeks.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09