Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, 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 Menopause Rating Scale (MRS) Total Score
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract in women experiencing perimenopausal symptoms. Participants will receive either Shatavari root extract or a matched placebo for 12 weeks. Efficacy will be assessed using validated menopause-specific symptom, quality-of-life, stress, mood, and sleep questionnaires, along with physiological stress markers. Safety will be evaluated through laboratory assessments and adverse event monitoring.
详细描述
Perimenopause is characterized by fluctuating estrogen levels that contribute to vasomotor symptoms, mood disturbances, sleep disorders, and reduced quality of life. Shatavari (Asparagus racemosus) is a traditionally used Ayurvedic herb known for its adaptogenic and phytoestrogenic properties, supporting hormonal balance and stress regulation.
This multi-center, prospective, randomized, double-blind, parallel-group study will enroll 160 perimenopausal women in India and the United States. Eligible participants will be randomized in a 1:1 ratio to receive either a standardized Shatavari root extract capsule (300 mg/day) or a matched placebo for 12 weeks. Primary efficacy will be assessed using the Menopause Rating Scale (MRS). Secondary outcomes include menopause-specific quality of life, hot flash interference, perceived stress, mood, sleep quality, and salivary cortisol measures. Safety will be evaluated through laboratory investigations and monitoring of 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
- 40 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menopausal women aged >40 to 45 years with intact uterus and ovaries.
- •Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
- •Females with complaints of at least two of the menopausal symptoms, e.g., hot flashes, night sweats, mood swings, sleep disturbance, breast tenderness
- •Body mass index 18-35 kg/m2
- •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 si
排除标准
- •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 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 result difficult.
- •Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Participants with evidence of demonstrated inability to follow study protocols or attend follow-up visits, including poor compliance.
- •Participants with demonstrated inability to follow study protocols or attend follow-up visit
- •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 (SRI-81) 300 mg
Participants will receive a standardized Shatavari (Asparagus racemosus) root extract capsule containing 300 mg, administered orally once daily after breakfast with water for 12 weeks.
干预措施: Shatavari (Asparagus racemosus) Root Extract (Dietary Supplement)
Placebo Capsule (Starch) 300 mg
Participants will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks.
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Change in Menopause Rating Scale (MRS) Total Score
时间窗: Baseline, Week 4, Week 8, Week 12
The Menopause Rating Scale (MRS) is a validated 11-item questionnaire assessing the severity of menopausal symptoms across three domains: psychological, somato-vegetative, and urogenital. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 44, with higher scores indicating more severe menopausal symptoms (worse outcome). This outcome measures the mean change from baseline in MRS total score, where a reduction in score indicates improvement in overall perimenopausal symptom burden.
次要结局
- Change in Menopause-Specific Quality of Life (MENQOL) Scores(Baseline, Week 4, Week 8, Week 12)
- Change in Hot Flash-Related Daily Interference Scale (HFRDIS) Scores(Baseline, Week 4, Week 8, Week 12)
- Change in Perceived Stress Scale (PSS-10) Scores(Baseline, Week 4, Week 8, Week 12)
- Change in Pittsburgh Sleep Quality Index (PSQI) Scores(Baseline, Week 4, Week 8, Week 12)
- Change in Profile of Mood States (POMS) Scores(Baseline, Week 4, Week 8, Week 12)
- Change in Salivary Cortisol Awakening Response (CAR)(Baseline and Week 12)
- Change in Bedtime Salivary Cortisol Levels(Baseline and Week 12)
- Change in Liver Function Test Parameters (ALT, AST, ALP, Bilirubin)(Baseline and Week 12)
- Change in Renal Function Test Parameters (Serum Creatinine, BUN)(Baseline and Week 12)
- Change in Thyroid Function Test Parameters (T3, T4, TSH)(Baseline and Week 12)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Baseline, Week 4, Week 8, Week 12)
- Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)(Baseline, Week 4, Week 8, Week 12)