Perimenopause, Women Health
Conditions
Keywords
Shatavari, Dietary Supplement
Brief summary
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.
Detailed description
Perimenopause is characterized by fluctuating estrogen levels that contribute to vasomotor symptoms, mood disturbances, sleep disorders, and reduced quality of life. Shatavari (Asparagus racemosus) is a traditionally used Ayurvedic herb known for its adaptogenic and phytoestrogenic properties, supporting hormonal balance and stress regulation. This multi-center, prospective, randomized, double-blind, parallel-group study will enroll 160 perimenopausal women in India and the United States. Eligible participants will be randomized in a 1:1 ratio to receive either a standardized Shatavari root extract capsule (300 mg/day) or a matched placebo for 12 weeks. Primary efficacy will be assessed using the Menopause Rating Scale (MRS). Secondary outcomes include menopause-specific quality of life, hot flash interference, perceived stress, mood, sleep quality, and salivary cortisol measures. Safety will be evaluated through laboratory investigations and monitoring of adverse events.
Interventions
DIETARY_SUPPLEMENTShatavari (Asparagus racemosus) Root Extract
A 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.
OTHERPlacebo Capsule
An inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding.
Sponsors
SF Research Institute, Inc.
Ixoreal Biomed Private Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Menopausal women aged \>40 to 45 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 at least two of the menopausal symptoms, e.g., hot flashes, night sweats, mood swings, sleep disturbance, breast tenderness 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 willingness to si
Exclusion criteria
1. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with present active medical, surgical, and gynaecological problems. 5. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 6. Participants who had undergone bilateral ovariectomy 7. Participants with history of breast or cervical carcinoma 8. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 9. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult. 10. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 11. Participants with evidence of demonstrated inability to follow study protocols or attend follow-up visits, including poor compliance. 12. Participants with demonstrated inability to follow study protocols or attend follow-up visit 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. Patients who have any clinical condition, according to the investigator, who does not allow safe fulfilment of clinical trial protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menopause Rating Scale (MRS) Total Score | Baseline, Week 4, Week 8, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menopause-Specific Quality of Life (MENQOL) Scores | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Hot Flash-Related Daily Interference Scale (HFRDIS) Scores | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Perceived Stress Scale (PSS-10) Scores | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Scores | Baseline, Week 4, Week 8, Week 12 | 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. |
| Change in Profile of Mood States (POMS) Scores | Baseline, Week 4, Week 8, Week 12 | The Profile of Mood States (POMS) is a validated questionnaire assessing mood disturbance across six domains: tension, depression, anger, vigor, fatigue, and confusion. The Total Mood Disturbance (TMD) score typically ranges from -32 to 200 (depending on scoring method), with higher scores indicating greater mood disturbance (worse outcome). This outcome measures the mean change from baseline in POMS Total Mood Disturbance (TMD) and subscale scores, where a reduction in TMD score indicates improvement in overall mood state. |
| Change in Salivary Cortisol Awakening Response (CAR) | Baseline and Week 12 | Salivary cortisol awakening response (CAR) reflects hypothalamic-pituitary-adrenal (HPA) axis activity and physiological stress response. This outcome measures the mean change from baseline in salivary cortisol levels collected immediately upon awakening and 30 minutes post-awakening. |
| Change in Bedtime Salivary Cortisol Levels | Baseline and Week 12 | Bedtime salivary cortisol reflects diurnal cortisol rhythm and stress regulation. This outcome measures the mean change from baseline in bedtime salivary cortisol levels collected during late evening hours. |
| Change in Liver Function Test Parameters (ALT, AST, ALP, Bilirubin) | Baseline and Week 12 | Hepatic safety will be assessed using serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin levels. This outcome measures mean changes from baseline to monitor liver safety during the study. |
| Change in Renal Function Test Parameters (Serum Creatinine, BUN) | Baseline and Week 12 | Renal safety will be assessed using serum creatinine and blood urea nitrogen (BUN). This outcome measures mean changes from baseline to evaluate kidney function during the intervention. |
| Change in Thyroid Function Test Parameters (T3, T4, TSH) | Baseline and Week 12 | Thyroid safety will be assessed using serum triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH). This outcome measures mean changes from baseline to monitor endocrine function. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Baseline, Week 4, Week 8, Week 12 | Treatment-emergent adverse events (TEAEs) are defined as adverse events occurring or worsening after initiation of the study intervention. This outcome measures the number and proportion of participants experiencing one or more TEAEs. |
| Incidence of Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline, Week 4, Week 8, Week 12 | Treatment-emergent serious adverse events (TESAEs) include events that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, or result in significant disability. This outcome measures the number and proportion of participants experiencing TESAEs. |
Countries
United States
Contacts
CONTACTDr. John Ademola
Outcome results
None listed