Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study
SF Research Institute, Inc.
Summary
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.
Description
To qualify for the study, participants must be 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. Women with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. In this study, a maximum of 51 patients will be enrolled and the goal is to complete the study with at least 45 patients. After signing this con…
Eligibility
- Age range
- 45–55 years
- Sex
- Female
- Healthy volunteers
- Yes
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 rea…
Interventions
- Dietary SupplementShatavari extract
Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
- Dietary SupplementShatavari + Ashwagandha extract
Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.
- Dietary SupplementPlacebo
Placebo (starch)
Location
- SF Research Institute, Inc.San Francisco, California