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

Inclusion Criteria

• Menopausal women aged 45 to 65 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 menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
• 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 sign an 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 who are on hormone replacement therapy (HRT) for more than 3 months.
• 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 uncooperative attitude, including poor compliance.
• 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 with known hypersensitivity to Ashwagandha.
• 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