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

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.