[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658602":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":56,"studyPopulation":42,"armGroups":57,"interventions":70,"overallOfficials":42,"centralContacts":79,"locations":42,"responsibleParty":85,"collaborators":42,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":42,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":42,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":42,"overallStatus":108,"whyStopped":42,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":42},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,23,26,29,33,36,39],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":32},"Change in Serum Follicle-Stimulating Hormone (FSH) Level","Change from baseline in serum follicle-stimulating hormone (FSH) concentration.","Baseline to Week 8",{"measure":34,"description":35,"timeFrame":32},"Change in Serum Luteinizing Hormone (LH) Level","Change from baseline in serum luteinizing hormone (LH) concentration.",{"measure":37,"description":38,"timeFrame":32},"Change in Serum Estradiol Level","Change from baseline in serum estradiol concentration.",{"measure":40,"description":41,"timeFrame":32},"Change in Serum Total Testosterone Level","Change from baseline in serum total testosterone concentration.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to receive either Shaktiva™ 300 mg\u002Fday or matching placebo for 8 weeks.","TREATMENT",{"masking":49,"maskingDescription":50,"whoMasked":51},"QUADRUPLE","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.",[52,53,54,55],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nAsparagus 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.\n\nThe 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\u002For 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.\n\nThe 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\u002Finsomnia, and health-related quality of life. Selected circulating hormones will also be assessed on an exploratory basis.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Asparagus racemosus extract supplement (Shaktiva™)","EXPERIMENTAL","Participants will receive Shaktiva™ (Asparagus racemosus extract) 300 mg orally once daily for 8 weeks.",[63],"Dietary Supplement: Asparagus racemosus Extract (Shaktiva™)",{"label":65,"type":66,"description":67,"interventionNames":68},"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.",[69],"Other: Placebo",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":42},"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.",[59],{"type":6,"name":65,"description":77,"armGroupLabels":78,"otherNames":42},"A matching placebo designed to be identical, as far as practicable, to the active intervention in appearance, size, colour, taste, packaging, and administration schedule.",[65],[80],{"name":81,"role":82,"phone":83,"phoneExt":42,"email":84},"Dr Amjad Khan, DPhil","CONTACT","03000506955","amjadkhan@lumhs.edu.pk",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental Medicine","100658602","study-to-investigate-asparagus-racemosus-extract-shaktiva-for-psychological-symptoms-in-perimenopausal-women-100658602",false,"NCT07853560","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","Inclusion Criteria:\n\nParticipants must meet all of the following:\n\n* Female participants aged 40-55 years.\n* 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 \\\u003C12 months.\n* Have experienced at least one menstrual period within the preceding 12 months.\n* 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.\n* Willing to maintain their usual diet and lifestyle throughout the study.\n* Willing to refrain from starting other supplements intended for menopausal symptoms, mood, anxiety, stress, or sleep during the study.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following apply:\n\n* Postmenopausal status, defined as ≥12 consecutive months of amenorrhoea.\n* Current use of menopausal hormone therapy (HRT\u002FMHT) or other hormonal therapy likely to influence menopausal symptoms or study hormone measurements.\n* Current use of antidepressant medication.\n* Current regular use of anxiolytic or other psychotropic medication likely to materially influence mood, anxiety, or stress outcomes.\n* Current regular use of prescription or over-the-counter sleep medication\u002Fhypnotics likely to influence sleep outcomes.\n* Use of herbal or dietary supplements specifically intended to treat menopausal symptoms, mood, anxiety, stress, or sleep within the 4 weeks before screening.\n* History of bilateral oophorectomy or surgical menopause.\n* Clinically significant psychiatric disorder requiring active specialist psychiatric management.\n* Current severe major depressive episode, clinically significant suicidal ideation, or other psychiatric condition requiring immediate clinical intervention.\n* Clinically significant uncontrolled endocrine disease, including uncontrolled thyroid disease.\n* 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.\n* Current or recent alcohol or substance abuse.\n* Known hypersensitivity to any constituent of the investigational product or placebo.\n* Participation in another clinical intervention study within the preceding 3 months.\n* Pregnancy, breastfeeding, or intention to become pregnant during the study.\n* Any other condition considered by the investigator to make participation unsafe or interfere with protocol compliance.","FEMALE","40 Years","55 Years",{"count":100,"type":101},100,"ESTIMATED","INTERVENTIONAL",[104],"NA","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.\n\nThis 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.",[107],"Perimenopausal Disorder","NOT_YET_RECRUITING","2026-09-26",{"date":111,"type":112},"2026-10-02","ACTUAL",{"date":114,"type":101},"2026-12-01",{"date":116,"type":101},"2027-03-31",{"name":5,"class":6}]