Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract in Women's Sexual Wellness: A Prospective, 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 Female Sexual Function Index (FSFI) total score
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness. Sexual wellness is assessed as a multidimensional construct encompassing sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers. Participants will receive either Shatavari root extract or placebo for 12 weeks, with assessments conducted at baseline and follow-up visits.
详细描述
Women's sexual wellness is influenced by biological, psychological, and social factors. Stress and neuroendocrine imbalance play a central role in sexual dysfunction and distress. Shatavari (Asparagus racemosus), a traditional Ayurvedic herb, has been historically used to support female reproductive health, hormonal balance, and stress modulation.
This multi-national, prospective, randomized, double-blind, parallel-group study will enroll women aged 20 to 50 years in India and the United States. Eligible participants with reduced sexual function and elevated perceived stress will be randomized in a 1:1 ratio to receive either SRI-81 Shatavari root extract (300 mg/day) or a matched placebo for 12 weeks.
Efficacy will be primarily assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include sexual distress, sexual satisfaction, perceived stress, quality of life, salivary cortisol measures, and laboratory safety parameters. Safety will be evaluated through adverse event monitoring and laboratory investigations.
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
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 20 to 50 years of age.
- •Sexually active, attempting sexual activity, or experiencing concerns related to sexual desire or function, with a partner and have a FSFI total score ≤ 26.
- •Have a PSS-10 score of ≥ 14 at screening.
- •Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
- •Participants who are reliable, honest, compliant, and agree to co operate with all trial evaluations as well as to be able to perform them as per investigator's opinion.
- •Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- •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 a written informed consent and to comply with all study procedures.
排除标准
- •Participants taking any form of herbal extract in the last 3 months before study entry.
- •Participants with hormonal imbalance including PCOS, and symptoms of perimenopause and menopause
- •Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •Participants with any active medical, surgical, or gynaecological problems.
- •Participants with a history of alcohol, tobacco dependence, or any other substance abuse
- •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 demonstrated inability to comply with the study procedures, including poor compliance.
- •Participants with inability to attend follow-up visits.
- •Patients with known hypersensitivity to Shatavari, or any of the ingredients of study interventions.
- •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 randomized to this arm will receive a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) capsule containing 300 mg, administered orally once daily after breakfast with water for a duration of 12 weeks. The intervention is intended to evaluate the efficacy and safety of Shatavari root extract in improving women's sexual wellness, including sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers, compared with placebo.
干预措施: Shatavari (Asparagus racemosus) Root Extract (Dietary Supplement)
Placebo Capsule (Starch) 300 mg
Participants randomized to this arm will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. The placebo is matched in appearance, color, and packaging to the active intervention to maintain blinding. This arm serves as the comparator for evaluating the efficacy and safety of Shatavari root extract in women's sexual wellness.
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Change in Female Sexual Function Index (FSFI) total score
时间窗: Baseline, Week 4, Week 8, Week 12
The Female Sexual Function Index (FSFI) is a validated 19-item self-reported questionnaire assessing female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2.0 to 36.0, with higher scores indicating better sexual function (better outcome). This outcome measures the mean change from baseline in FSFI total score, where an increase in score indicates improvement in female sexual function.
次要结局
- Change in Female Sexual Distress Scale (FSDS) Score(Baseline, Week 4, Week 8, Week 12)
- Change in Thyroid Function Test Parameters (T3, T4, TSH)(Baseline and Week 12)
- Change in Global Measure of Sexual Satisfaction (GMSEX) Score(Baseline, Week 4, Week 8, Week 12)
- Change in Perceived Stress Scale (PSS-10) Score(Baseline, Week 4, Week 8, Week 12)
- Change in PROMIS-29 Quality-of-Life 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(Baseline and Week 12)
- Change in Renal Function Test Parameters(Baseline and Week 12)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Baseline to Week 12)
- Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)(Baseline to Week 12)