Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Dietary supplement Shatavari (Asparagus racemosus) Root Extract
  The investigational intervention is a standardized Shatavari (Asparagus racemosus Willd.) root extract (SRI-81), manufactured under current Good Manufacturing Practice (cGMP) conditions. Each capsule contains 300 mg of Shatavari root extract with an herb-to-extract ratio of 13:1 and is standardized to contain ≥10% total Shatavarins, quantified by high-performance liquid chromatography (HPLC). Participants will self-administer one capsule orally once daily after breakfast with water for 12 weeks.
• Other Placebo Capsule
  The placebo intervention consists of an orally administered capsule containing 300 mg of inert starch. The placebo capsules are identical in size, color, appearance, and packaging to the active Shatavari intervention to ensure double blinding of participants and study personnel. Participants will self-administer one capsule once daily after breakfast with water for 12 weeks. The placebo contains no active herbal or pharmacological ingredients and is used solely for comparison with the investigat

Primary outcome measures

• Change in Female Sexual Function Index (FSFI) total score [Time frame: Baseline, Week 4, Week 8, Week 12]

Secondary outcome measures (11)

• Change in Female Sexual Distress Scale (FSDS) Score [Time frame: Baseline, Week 4, Week 8, Week 12]
• Change in Global Measure of Sexual Satisfaction (GMSEX) Score [Time frame: Baseline, Week 4, Week 8, Week 12]
• Change in Perceived Stress Scale (PSS-10) Score [Time frame: Baseline, Week 4, Week 8, Week 12]
• Change in PROMIS-29 Quality-of-Life Scores [Time frame: Baseline, Week 4, Week 8, Week 12]
• Change in Salivary Cortisol Awakening Response (CAR) [Time frame: Baseline and Week 12]
• Change in Bedtime Salivary Cortisol Levels [Time frame: Baseline and Week 12]
• Change in Thyroid Function Test Parameters (T3, T4, TSH) [Time frame: Baseline and Week 12]
• Change in Liver Function Test Parameters [Time frame: Baseline and Week 12]
• Change in Renal Function Test Parameters [Time frame: Baseline and Week 12]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Baseline to Week 12]
• Incidence of Treatment-Emergent Serious Adverse Events (TESAEs) [Time frame: Baseline to Week 12]

Eligibility criteria

Inclusion criteria

• 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 ≤ 26.55.
• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• San Francisco Research Institute — San Francisco

Identifiers

NCT: NCT07441083 · Ixo/2025/1314/SHT/SexWel/GB/01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗