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

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.

NCT Number	NCT06716554
Lead Sponsor	SF Research Institute, Inc. Collaborators: Ixoreal Biomed Inc.
Conditions	Menopause, Hot Flashes, Mood
Enrollment	51 participants
Start Date	2024-10-26
Primary Completion	2024-12-26 (estimated)
Study Completion	2025-01-20 (estimated)
Updated on ClinicalTrials.gov	2024-12-04