Using Shatavari to treat menopausal symptoms in women

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

This study is testing if Shatavari can help women aged 45 to 65 feel better during menopause by reducing symptoms like hot flashes and mood swings.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 45 Years to 55 Years
• Sex: Female
• Sponsor: SF Research Institute, Inc. (Research network)
• Drugs / interventions: methotrexate
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06716554 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Shatavari for treating menopausal symptoms in women aged 45 to 65. Participants will be randomly assigned to receive either Shatavari, Shatavari combined with Ashwagandha, or a placebo for eight weeks. Throughout the study, participants will maintain their usual diet and physical activity, and their health will be monitored through physical exams and blood tests. The primary goal is to assess how effective Shatavari is in alleviating symptoms such as hot flashes and mood changes.

Who should consider this trial

Good fit: Ideal candidates are menopausal women aged 45 to 65 with intact uterus and ovaries who experience menopausal symptoms.

Not a fit: Patients currently on hormone replacement therapy or those who have taken herbal extracts in the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural treatment option for women experiencing menopausal symptoms.

How similar studies have performed: While the use of Shatavari is gaining interest, this specific approach is relatively novel and has not been extensively tested in similar studies.

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

Where this trial is running

San Francisco, California

• SF Research Institute, Inc. — San Francisco, California, United States (Recruiting)

Study contacts

• Study coordinator: Khaleeq Rehman

Conditions Menopause; Hot Flashes; Mood