Perimenopausal DisorderNCT07853560
Study to Investigate Asparagus Racemosus Extract (Shaktiva™) for Psychological Symptoms in Perimenopausal Women
A study testing Asparagus racemosus Extract (Shaktiva™) in people with Perimenopausal Disorder, run by Liaquat University of Medical & Health Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Perimenopausal Disorder
- What is being tested?
- Asparagus racemosus Extract (Shaktiva™)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
Perimenopause is characterized by changes in ovarian function, hormonal fluctuations, and menstrual-cycle irregularity and may be associated with psychological, physical, vasomotor, urogenital, and sleep-related symptoms. In particular, women may experience increased symptoms of depression, anxiety, and stress during the menopausal transition.
Asparagus racemosus (Shatavari) is a medicinal plant traditionally used in relation to women's health. Previous randomized controlled trials of standardized Shatavari extracts have reported improvements in menopausal symptom burden and psychological outcomes. However, psychological symptoms have generally been evaluated as part of broader menopausal symptom assessments rather than as the primary focus of investigation.
The present study is an 8-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to investigate the effects of Shaktiva™, a standardised Asparagus racemosus extract, in perimenopausal women with mild-to-moderate symptoms of depression, anxiety and/or stress. One hundred eligible participants will be randomized in a 1:1 ratio to receive Shaktiva™ 300 mg once daily or matching placebo for 8 weeks.
The main focus of the study is the effect of Shaktiva™ on depression, anxiety, and stress. Additional assessments will examine positive and negative affect, mental wellbeing, menopausal symptom burden, sleep/insomnia, and health-related quality of life. Selected circulating hormones will also be assessed on an exploratory basis.
- Conditions
- Perimenopausal Disorder
- Being tested
- Asparagus racemosus Extract (Shaktiva™), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
A matching placebo designed to be identical, as far as practicable, to the active intervention in appearance, size, colour, taste, packaging, and administration schedule.
| Study group | Role | What they receive |
|---|---|---|
| Asparagus racemosus extract supplement (Shaktiva™) | Experimental | Participants will receive Shaktiva™ (Asparagus racemosus extract) 300 mg orally once daily for 8 weeks. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4 and Week 8
Secondary outcomes (9)
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.
Measured: Baseline to Week 4 and Week 8
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.
Measured: Baseline to Week 4 and Week 8
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.
Measured: Baseline to Week 4 and Week 8
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.
Measured: Baseline to Week 4 and Week 8
Change in SF-36 Health-Related Quality of Life Scores
Change from baseline in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36). The SF-36 assesses eight physical and mental health domains, with domain scores ranging from 0 to 100; higher scores indicate better perceived health and functioning. Physical and mental component summary scores will also be derived.
Measured: Baseline to Week 4 and Week 8
Change in Serum Follicle-Stimulating Hormone (FSH) Level
Change from baseline in serum follicle-stimulating hormone (FSH) concentration.
Measured: Baseline to Week 8
Change in Serum Luteinizing Hormone (LH) Level
Change from baseline in serum luteinizing hormone (LH) concentration.
Measured: Baseline to Week 8
Change in Serum Estradiol Level
Change from baseline in serum estradiol concentration.
Measured: Baseline to Week 8
Change in Serum Total Testosterone Level
Change from baseline in serum total testosterone concentration.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either Shaktiva™ 300 mg/day or matching placebo for 8 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853560
- Sponsor's protocol ID
- LUMHS/REC/Temp/26.09.2026
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07853560
- Acronym / sponsor ID
- LUMHS/REC/Temp/26.09.2026
- Conditions
- Perimenopausal Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Perimenopause is characterized by changes in ovarian function, hormonal fluctuations, and menstrual-cycle irregularity and may be associated with psychological, physical, vasomotor, urogenital, and sleep-related symptoms. In particular, women may experience increased symptoms of depression, anxiety, and stress during the menopausal transition.
Asparagus racemosus (Shatavari) is a medicinal plant traditionally used in relation to women's health. Previous randomized controlled trials of standardized Shatavari extracts have reported improvements in menopausal symptom burden and psychological outcomes. However, psychological symptoms have generally been evaluated as part of broader menopausal symptom assessments rather than as the primary focus of investigation.
The present study is an 8-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to investigate the effects of Shaktiva™, a standardised Asparagus racemosus extract, in perimenopausal women with mild-to-moderate symptoms of depression, anxiety and/or stress. One hundred eligible participants will be randomized in a 1:1 ratio to receive Shaktiva™ 300 mg once daily or matching placebo for 8 weeks.
The main focus of the study is the effect of Shaktiva™ on depression, anxiety, and stress. Additional assessments will examine positive and negative affect, mental wellbeing, menopausal symptom burden, sleep/insomnia, and health-related quality of life. Selected circulating hormones will also be assessed on an exploratory basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either Shaktiva™ 300 mg/day or matching placebo for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Asparagus racemosus extract supplement (Shaktiva™) | Experimental | Dietary Supplement: Asparagus racemosus Extract (Shaktiva™)Participants will receive Shaktiva™ (Asparagus racemosus extract) 300 mg orally once daily for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asparagus racemosus Extract (Shaktiva™)A standardised Asparagus racemosus (Shatavari) extract administered orally at a dose of 300 mg once daily for 8 weeks. | Dietary supplement | Asparagus racemosus extract supplement (Shaktiva™) |
| PlaceboA matching placebo designed to be identical, as far as practicable, to the active intervention in appearance, size, colour, taste, packaging, and administration schedule. | Other | Placebo |
Primary outcome
Change in DASS-42 Depression Subscales Scores
Time frame: Baseline to Week 4 and Week 8
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.
9 secondary outcomes
Change in Positive and Negative Affect Schedule (PANAS) Scores
Time frame: Baseline to Week 4 and Week 8
Change in Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) Total Score
Time frame: Baseline to Week 4 and Week 8
Change in Menopause Rating Scale (MRS) Scores
Time frame: Baseline to Week 4 and Week 8
Change in Regensburg Insomnia Scale (RIS) Total Score
Time frame: Baseline to Week 4 and Week 8
Change in SF-36 Health-Related Quality of Life Scores
Time frame: Baseline to Week 4 and Week 8
Change in Serum Follicle-Stimulating Hormone (FSH) Level
Time frame: Baseline to Week 8
Change in Serum Luteinizing Hormone (LH) Level
Time frame: Baseline to Week 8
Change in Serum Estradiol Level
Time frame: Baseline to Week 8
Change in Serum Total Testosterone Level
Time frame: Baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Asparagus racemosus Extract (Shaktiva™) in people with Perimenopausal Disorder, run by Liaquat University of Medical & Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Amjad Khan, DPhil (03000506955, amjadkhan@lumhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DASS-42 Depression Subscales Scores (time frame: Baseline to Week 4 and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.