Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study
SF Research Institute, Inc.
Summary
Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life. This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.
Description
Premenstrual syndrome (PMS) is characterized by recurrent emotional, physical, and behavioral symptoms that occur during the luteal phase of the menstrual cycle and resolve shortly after the onset of menstruation. A significant proportion of women experience PMS, and in many cases the symptoms are severe enough to impair daily functioning, work productivity, and interpersonal relationships. Hormonal fluctuations, stress sensitivity, and neuroendocrine dysregulation are considered key contributors to the condition. Shatavari (Asparagus racemosus) is a traditional Ayurvedic herb widely used to…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy women aged 18-40 years with intact uterus and ovaries. 2. Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP. 3. PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD. 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 read and write in English or any other vernacular language. 7. No plan to commence new treatments over the study period. 8. Must have the ability and willing…
Interventions
- Dietary SupplementShatavari Root Extract
Shatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks.
- OtherPlacebo Capsule
The placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks.
Location
- San Francisco Research InstituteSan Francisco, California