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.
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
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
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Inc.
Collaborator