An interventional study of Shatavari Root Extract and Placebo Capsule in Premenstrual Syndrome and Women Health, sponsored by SF Research Institute, Inc.. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by SF Research Institute, Inc. · Not applicable, Interventional, and Treatment
Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life.
This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.
Premenstrual syndrome (PMS) is characterized by recurrent emotional, physical, and behavioral symptoms that occur during the luteal phase of the menstrual cycle and resolve shortly after the onset of menstruation. A significant proportion of women experience PMS, and in many cases the symptoms are severe enough to impair daily functioning, work productivity, and interpersonal relationships. Hormonal fluctuations, stress sensitivity, and neuroendocrine dysregulation are considered key contributors to the condition.
Shatavari (Asparagus racemosus) is a traditional Ayurvedic herb widely used to support women's reproductive health. It is regarded as an adaptogenic and hormonal-modulating botanical, containing bioactive constituents such as steroidal saponins (shatavarins) that may help regulate hormonal balance and stress response. Traditional use and emerging scientific evidence suggest that Shatavari may be beneficial in alleviating mood disturbances, fatigue, sleep problems, and stress-related symptoms commonly associated with PMS.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of a standardized Shatavari root extract in women with mild to moderate PMS. Approximately 160 premenopausal women aged 18 to 40 years will be enrolled across study sites in India and the United States. Eligibility will be confirmed using clinical history and prospective symptom assessment with the Daily Record of Severity of Problems (DRSP) during a baseline cycle.
Participants will be randomized in a 1:1 ratio to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. Study visits will occur at baseline and at Weeks 4, 8, and 12. Efficacy will be evaluated using validated patient-reported outcome measures including the DRSP, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and Women's Quality of Life Questionnaire (WOMQOL). Neuroendocrine stress response will be assessed through salivary cortisol measurements, including cortisol awakening response and bedtime cortisol levels, collected at baseline and at the end of the study.
Safety will be monitored throughout the study through physical examinations, vital signs, laboratory assessments of liver, renal, and thyroid function, and systematic recording of treatment-emergent adverse events and serious adverse events.
The findings of this study are expected to provide clinical evidence regarding the efficacy, safety, and tolerability of Shatavari root extract for the management of premenstrual syndrome symptoms and to support future confirmatory clinical research.
177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →SF Research Institute, Inc. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks.
Dietary Supplement: Shatavari Root Extract
Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks.
Other: Placebo Capsule
Shatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks.
The placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks.
Change in Daily Record of Severity of Problems (DRSP) Total Score
The Daily Record of Severity of Problems (DRSP) is a validated patient-reported questionnaire used to assess emotional, physical, and functional symptoms associated with premenstrual syndrome (PMS). The DRSP consists of 21 items scored daily from 1 (not at all) to 6 (extreme). The total score ranges from 21 to 126, with higher scores indicating greater symptom severity (worse outcome). DRSP scores will be recorded daily and averaged/summarized for each assessment visit. This outcome measures the mean change from baseline in DRSP total score, where a reduction in score indicates improvement in premenstrual symptom severity.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Perceived Stress Scale (PSS) Score
The Perceived Stress Scale (PSS-10) is a validated 10-item questionnaire assessing the degree to which situations in life are appraised as stressful. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). This outcome measures the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire evaluating sleep quality and disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). This outcome measures the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Women's Quality of Life Questionnaire (WOMQOL) Score
The Women's Quality of Life Questionnaire (WOMQOL) evaluates quality of life across physical, psychological, social, and spiritual domains. The total score ranges from 0 to 100, with higher scores indicating better quality of life (better outcome). This outcome measures the mean change from baseline in WOMQOL total score, where an increase in score indicates improvement in overall quality of life.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Bedtime Salivary Cortisol Level
This outcome evaluates changes in bedtime salivary cortisol levels as a biomarker of stress response. Saliva samples will be collected at bedtime and analyzed using standardized immunoassay methods.
Time frame: Baseline and Week 12
Change in Cortisol Awakening Response (CAR)
This outcome measures changes in the cortisol awakening response (CAR), assessed by salivary cortisol collected immediately upon awakening and 30 minutes post-awakening, reflecting hypothalamic-pituitary-adrenal axis activity.
Time frame: Baseline and Week 12
Change in Liver Function Parameters
This outcome assesses the mean change in liver function parameters including serum alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), and bilirubin to evaluate hepatic safety of the intervention.
Time frame: Baseline and Week 12
Change in Renal Function Parameters
This outcome evaluates the mean change in renal function parameters including serum creatinine and blood urea nitrogen to assess renal safety during the study period.
Time frame: Baseline and Week 12
Change in Thyroid Function Parameters
This outcome assesses the mean change in thyroid function parameters including triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH) to monitor thyroid safety.
Time frame: Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
This outcome measures the number and proportion of participants experiencing treatment-emergent adverse events during the study period, regardless of relationship to the study intervention.
Time frame: Baseline, Week 4, Week 8, and Week 12
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
This outcome measures the number and proportion of participants experiencing treatment-emergent serious adverse events during the study period.
Time frame: Baseline, Week 4, Week 8, and Week 12
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