Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Eligibility Criteria

• 1. Menopausal women aged 45 to 65 years with intact uterus and ovaries.
• 2. 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
• 3. Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
• 4. Body mass index 18-35 kg/m2
• 5. Subject who has given written informed consent to participate in the study and understand the nature of the study
• 6. Able to read and write in English or any other vernacular language
• 7. No plan to commence new treatments over the study period.
• 8. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
• 1. Participants taking any form of herbal extract in the last 3 months before study entry.
• 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months.
• 3. Participants with Present active medical, surgical, and gynaecological problems.
• 4. Participants with a history of alcohol, tobacco dependence, or any substance abuse
• 5. Participants who had undergone bilateral ovariectomy
• 6. Participants with history of breast or cervical carcinoma
• 7. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
• 8. 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
• 9. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• 10. Participants with evidence of uncooperative attitude, including poor compliance.
• 11. Participants with inability to attend follow-up visit
• 12. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
• 13. Patients with known hypersensitivity to Ashwagandha.
• 14. Patients who had participated in other clinical trials during the previous 3 months.
• 15. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol