Premenstrual Syndrome, Women Health
Conditions
Keywords
PMS, Shatavari, Asparagus racemosus
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTShatavari Root Extract
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.
OTHERPlacebo Capsule
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.
Sponsors
SF Research Institute, Inc.
Ixoreal Biomed Private Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy women aged 18-40 years with intact uterus and ovaries. 2. Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP. 3. PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD. 4. Body mass index 18-35 kg/m2. 5. Subject who has given written informed consent to participate in the study and understand the nature of the study. 6. Able to read and write in English or any other vernacular language. 7. No plan to commence new treatments over the study period. 8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion criteria
* 1\. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months (cycle length variability \>7 days), ≥2 missed cycles in the past 12 months, or amenorrhea ≥60 days. 5. Participants with Present active medical, surgical, and gynaecological problems. 6. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 7. Participants who had undergone bilateral ovariectomy 8. Participants with history of breast or cervical carcinoma 9. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 10. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study results difficult. 11. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow-up visits. 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Record of Severity of Problems (DRSP) Total Score | Baseline, Week 4, Week 8, and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress Scale (PSS) Score | Baseline, Week 4, Week 8, and Week 12 | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline, Week 4, Week 8, and Week 12 | 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. |
| Change in Women's Quality of Life Questionnaire (WOMQOL) Score | Baseline, Week 4, Week 8, and Week 12 | 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. |
| Change in Bedtime Salivary Cortisol Level | Baseline and Week 12 | 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. |
| Change in Cortisol Awakening Response (CAR) | Baseline and Week 12 | 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. |
| Change in Liver Function Parameters | Baseline and Week 12 | 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. |
| Change in Renal Function Parameters | Baseline and Week 12 | 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. |
| Change in Thyroid Function Parameters | Baseline and Week 12 | This outcome assesses the mean change in thyroid function parameters including triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH) to monitor thyroid safety. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Baseline, Week 4, Week 8, and Week 12 | 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. |
| Incidence of Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline, Week 4, Week 8, and Week 12 | This outcome measures the number and proportion of participants experiencing treatment-emergent serious adverse events during the study period. |
Countries
United States
Contacts
CONTACTDr. John Ademola
Outcome results
None listed