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.
• 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
• Subject who has given written informed consent to participate in the study and understand the nature of the study
• Able to read and write in English or any other vernacular language
• No plan to commence new treatments over the study period.
• Must have the ability and willingness to sign an informed consent and to comply with all study procedures.