Shatavari Root Extract for Perimenopausal Symptoms

Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perimenopause; Women Health
• Intervention / Treatment: Dietary supplement: Shatavari (Asparagus racemosus) Root Extract; Other: Placebo Capsule

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. John Ademola; Phone Number: 415-845-4638; Email: jademola@sfinstitute.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94132
      • San Francisco Research Institute
      • Contact: Komal Makwana; Phone Number: 267-466-9000; Email: komalk.sfinstitute@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shatavari Root Extract (SRI-81) 300 mg; Participants will receive a standardized Shatavari (Asparagus racemosus) root extract capsule containing 300 mg, administered orally once daily after breakfast with water for 12 weeks.	Dietary supplement: Shatavari (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.
Placebo Comparator: Placebo Capsule (Starch) 300 mg; Participants will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks.	Other: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary Cortisol Awakening Response (CAR)	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.	Baseline and Week 12
Change in Bedtime Salivary Cortisol Levels	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.	Baseline and Week 12
Change in Liver Function Test Parameters (ALT, AST, ALP, Bilirubin)	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.	Baseline and Week 12
Change in Renal Function Test Parameters (Serum Creatinine, BUN)	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.	Baseline and Week 12
Change in Thyroid Function Test Parameters (T3, T4, TSH)	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.	Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)	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.	Baseline, Week 4, Week 8, Week 12
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)	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.	Baseline, Week 4, Week 8, Week 12
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.	Baseline, Week 4, Week 8, Week 12
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.	Baseline, Week 4, Week 8, Week 12
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.	Baseline, Week 4, Week 8, Week 12
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.	Baseline, Week 4, Week 8, Week 12
Change in Profile of Mood States (POMS) Scores	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.	Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: SF Research Institute, Inc.
• Collaborators: Ixoreal Biomed Private Limited

Study record dates

Study Major Dates

• Study Start (Estimated): March 11, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 29, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dietary Supplement; Shatavari
• Other Study ID Numbers: Ixo/2025/1341/SHT/Perime/GB/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No