Study of Shatavari Alone or With Ashwagandha for Treating Menopausal Symptoms in Women Aged 45 to 55 Years

What this Trial Is About

Researchers are evaluating the effects of Shatavari, a dietary supplement, for treating menopausal symptoms in women aged 45 to 65 years who have an intact uterus and ovaries. This randomized, double-blind, placebo-controlled study compares the safety and effectiveness of Shatavari alone, Shatavari combined with Ashwagandha, and a placebo. The main goal is to see how well Shatavari improves menopausal symptoms, with a secondary goal of assessing its safety. Participants will be randomly assigned to one of three groups taking a capsule of Shatavari 300 mg, a capsule combining Shatavari 300 mg and Ashwagandha 250 mg, or a placebo capsule containing starch. Each capsule is taken once daily in the morning after breakfast with water for 8 weeks. Participants will maintain their usual diet and physical activities throughout the study. The study plans to enroll up to 51 women and complete with at least 45. Participants will attend three visits a baseline visit at day 1, a mid-study visit at week 4, and an end-of-study visit at week 8. Assessments include physical exams, vital signs, blood tests measuring hormone levels estradiol, FSH, LH, testosterone, and questionnaires on menopausal symptoms, stress, mood, and quality of life. Participants will record their medication use and any side effects in diaries. The primary outcome is the change in Menopause Rating Scale scores, with secondary outcomes measuring stress, mood, quality of life, and hormone levels.

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