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
Parallel
Shatavari extract
Dietary supplementShatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
Shatavari + Ashwagandha extract
Dietary supplementShatavari 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.
Placebo
Dietary supplementPlacebo (starch)
Menopause Rating Scale (MRS)
The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS-10) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes several direct queries about current levels of experienced stress. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way
Menopause-Specific Quality of Life Questionnaire (MENQOL)
The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale.
Profile of Mood States (POMS, abbreviated version)
The POMS is a 40-item questionnaire rated on a 5-point Likert Scale, asking respondents how they feel right now. Scores are calculated for Tension, Anger, Fatigue, Depression, Esteem- related affect, Vigor, Confusion, and Total Mood Disturbance.
Serum Hormones
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SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Inc.
Collaborator
