Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorSF Research Institute, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy women aged 18-40 years with intact uterus and ovaries.
Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP.
PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD.
Body mass index 18-35 kg/m2.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Shatavari Root Extract
Dietary supplementShatavari (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.
Placebo Capsule
Other interventionThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Shatavari Root ExtractExperimental treatment 1 intervention
Group B: Placebo (Inactive capsule)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Private Limited
Collaborator
Source ClinicalTrials.gov
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