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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Shatavari (Asparagus racemosus) Root Extract
Dietary supplementA standardized Shatavari root extract manufactured under cGMP conditions with an herb-to-extract ratio of 13:1 and standardized to contain ≥10% total Shatavarins. Participants will self-administer one capsule daily for 12 weeks.
Placebo Capsule
Other interventionAn inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Shatavari Root Extract (SRI-81) 300 mgExperimental treatment 1 intervention
Group B: Placebo Capsule (Starch) 300 mgPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Menopause Rating Scale (MRS) Total Score
The Menopause Rating Scale (MRS) is a validated 11-item questionnaire assessing the severity of menopausal symptoms across three domains: psychological, somato-vegetative, and urogenital. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms). The total score ranges from 0 to 44, with higher scores indicating more severe menopausal symptoms (worse outcome). This outcome measures the mean change from baseline in MRS total score, where a reduction in score indicates improvement in overall perimenopausal symptom burden.
Time frame
Baseline, Week 4, Week 8, Week 12Secondary outcomes
1
Change in Menopause-Specific Quality of Life (MENQOL) Scores
The Menopause-Specific Quality of Life (MENQOL) questionnaire is a validated 29-item instrument assessing health-related quality of life across four domains: vasomotor, psychosocial, physical, and sexual. Each item is scored from 1 to 8, and domain scores are calculated as mean item scores. Total and domain scores range from 1 to 8, with higher scores indicating greater symptom burden and poorer quality of life (worse outcome). This outcome measures the mean change from baseline in MENQOL total and domain scores, where a decrease in score indicates improvement in menopause-related quality of life.
Time frame
Baseline, Week 4, Week 8, Week 122
Change in Hot Flash-Related Daily Interference Scale (HFRDIS) Scores
The Hot Flash-Related Daily Interference Scale (HFRDIS) is a validated instrument that assesses the degree to which hot flashes interfere with daily activities, work, sleep, mood, relationships, and overall quality of life. Each item is scored from 0 (does not interfere) to 10 (completely interferes). The total score ranges from 0 to 100, with higher scores indicating greater interference and worse functioning (worse outcome). This outcome measures the mean change from baseline in HFRDIS total score, where a reduction in score indicates improvement in hot flash-related daily functioning.
Time frame
Baseline, Week 4, Week 8, Week 123
Change in Perceived Stress Scale (PSS-10) Scores
The Perceived Stress Scale-10 (PSS-10) is a validated 10-item self-reported questionnaire measuring perceived stress over the previous month. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). This outcome measures the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress levels.
Time frame
Baseline, Week 4, Week 8, Week 124
Change in Pittsburgh Sleep Quality Index (PSQI) Scores
The Pittsburgh Sleep Quality Index (PSQI) is a validated instrument assessing subjective sleep quality and sleep disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). This outcome evaluates the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality.
Time frame
Baseline, Week 4, Week 8, Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Private Limited
Collaborator
Source ClinicalTrials.gov
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