Shatavari Root Extract for Perimenopausal Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-45
SponsorSF Research Institute, Inc.
About this trial
This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract in women experiencing perimenopausal symptoms. Participants will receive either Shatavari root extract or a matched placebo for 12 weeks. Efficacy will be assessed using validated menopause-specific symptom, quality-of-life, stress, mood, and sleep questionnaires, along with physiological stress markers. Safety will be evaluated through laboratory assessments and adverse event monitoring.
Eligibility criteria
Qualifiers
Menopausal women aged >40 to 45 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 at least two of the menopausal symptoms, e.g., hot flashes, night sweats, mood swings, sleep disturbance, breast tenderness
Body mass index 18-35 kg/m2
Disqualifiers
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 who are pregnant.
Participants with present active medical, surgical, and gynaecological problems.
Trial design
Treatments tested in this trial
- Shatavari (Asparagus racemosus) Root Extract
- Placebo Capsule
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Private Limited
Collaborator
Source ClinicalTrials.gov