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

Launched by SF RESEARCH INSTITUTE, INC. · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a natural supplement called Shatavari for treating symptoms related to menopause, such as hot flashes and mood changes. The trial involves women aged 45 to 65 who have experienced irregular menstrual cycles and common menopausal symptoms. To participate, women must not be on hormone replacement therapy or certain medications, and they should not have any serious medical conditions that could interfere with the study.

Participants in this study will randomly receive either Shatavari, a combination of Shatavari and another herb called Ashwagandha, or a placebo (a capsule that doesn’t contain any active ingredients). They will take one capsule daily for eight weeks while continuing their regular diet and activities. Throughout the study, the team will monitor how well the supplement works and how safe it is for the participants. This trial is currently recruiting, and women who are interested should ensure they meet the eligibility criteria before signing up.

Gender

FEMALE

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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