Shatavari Root Extract for Perimenopausal Symptoms

N/ANot Yet RecruitingNCT07441109

SF Research Institute, Inc.60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Perimenopause Women Health

Interventions

Shatavari (Asparagus racemosus) Root ExtractDIETARY_SUPPLEMENT

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 CapsuleOTHER

An inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

San Francisco Research Institute

San Francisco, California, United States

Outcomes

Primary Outcomes

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 12

Secondary Outcomes

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 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.

Time frame: Baseline, Week 4, Week 8, Week 12

Central Contacts

Dr. John Ademola

CONTACT

415-845-4638 jademola@sfinstitute.com

Data from ClinicalTrials.gov

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