Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Daily Record of Severity of Problems (DRSP) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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/m
- •Subject who has given written informed consent to participate in the study and understand the nature of the study.
- •Able to read and write in English or any other vernacular language.
- •No plan to commence new treatments over the study period.
- •Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •1. Participants taking any form of herbal extract in the last 3 months before study entry.
- •Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •Participants who are pregnant.
- •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.
- •Participants with Present active medical, surgical, and gynaecological problems.
- •Participants with a history of alcohol, tobacco dependence, or any substance abuse.
- •Participants who had undergone bilateral ovariectomy
- •Participants with history of breast or cervical carcinoma
- •Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- •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.
- •Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Participants with demonstrated inability to comply with study procedures or follow-up visits.
- •Participants with inability to attend follow-up visit
- •Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- •Patients who had participated in other clinical trials during the previous 3 months.
- •Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
研究组 & 干预措施
Shatavari Root Extract
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.
干预措施: Shatavari Root Extract (Dietary Supplement)
Placebo (Inactive capsule)
Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks.
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Change in Daily Record of Severity of Problems (DRSP) Total Score
时间窗: 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.
次要结局
- Change in Perceived Stress Scale (PSS) Score(Baseline, Week 4, Week 8, and Week 12)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, Week 4, Week 8, and Week 12)
- Change in Women's Quality of Life Questionnaire (WOMQOL) Score(Baseline, Week 4, Week 8, and Week 12)
- Change in Bedtime Salivary Cortisol Level(Baseline and Week 12)
- Change in Cortisol Awakening Response (CAR)(Baseline and Week 12)
- Change in Liver Function Parameters(Baseline and Week 12)
- Change in Renal Function Parameters(Baseline and Week 12)
- Change in Thyroid Function Parameters(Baseline and Week 12)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Baseline, Week 4, Week 8, and Week 12)
- Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)(Baseline, Week 4, Week 8, and Week 12)