PerimenopauseNCT07441109
Shatavari Root Extract for Perimenopausal Symptoms
A study testing Shatavari (Asparagus racemosus) Root Extract in people with Perimenopause and Women Health, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Women Health
- What is being tested?
- Shatavari (Asparagus racemosus) Root Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Subject who has given written informed consent to participate in the study and understand the nature of the study.
- Able to read and write in English or any other vernacular language.
- No plan to commence new treatments over the study period.
- Must have the ability and willingness to si
Who cannot join
- 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.
- Participants with a history of alcohol, tobacco dependence, or any substance abuse.
- Participants who had undergone bilateral ovariectomy
Show all 16Show fewer
- Participants with history of breast or cervical carcinoma
- Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- 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.
- Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Participants with evidence of demonstrated inability to follow study protocols or attend follow-up visits, including poor compliance.
- Participants with demonstrated inability to follow study protocols or attend follow-up visit
- Participants with inability to attend follow-up visit
- Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- Patients who had participated in other clinical trials during the previous 3 months.
- Patients who have any clinical condition, according to the investigator, who does not allow safe fulfilment of clinical trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Francisco Research Institute
San Francisco, California, 94132
Komal Makwana, 267-466-9000, komalk.sfinstitute@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Perimenopause, Women Health
- Being tested
- Shatavari (Asparagus racemosus) Root Extract, Placebo Capsule
- Keywords
- Shatavari, Dietary Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Shatavari Root Extract (SRI-81) 300 mg | Experimental | 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. Receives: Dietary Supplement: Shatavari (Asparagus racemosus) Root Extract |
| Placebo Capsule (Starch) 300 mg | Placebo comparator | Participants will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start11 Mar 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441109
- Sponsor's protocol ID
- Ixo/2025/1341/SHT/Perime/GB/08
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07441109
- Acronym / sponsor ID
- Ixo/2025/1341/SHT/Perime/GB/08
- Conditions
- Perimenopause, Women Health
- Keywords
- Shatavari, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Study start
- 11 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shatavari Root Extract (SRI-81) 300 mg | Experimental | Dietary Supplement: Shatavari (Asparagus racemosus) Root ExtractParticipants will receive a standardized Shatavari (Asparagus racemosus) root extract capsule containing 300 mg, administered orally once daily after breakfast with water for 12 weeks. |
| Placebo Capsule (Starch) 300 mg | Placebo comparator | Other: Placebo CapsuleParticipants will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- Subject who has given written informed consent to participate in the study and understand the nature of the study.
Key exclusion criteria (16 listed)
- 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.
- Participants with a history of alcohol, tobacco dependence, or any substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shatavari (Asparagus racemosus) Root ExtractA 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. | Dietary supplement | Shatavari Root Extract (SRI-81) 300 mg |
| Placebo CapsuleAn inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding. | Other | Placebo Capsule (Starch) 300 mg |
Primary outcome
Change in Menopause Rating Scale (MRS) Total Score
Time frame: 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.
12 secondary outcomes
Change in Menopause-Specific Quality of Life (MENQOL) Scores
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Hot Flash-Related Daily Interference Scale (HFRDIS) Scores
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Perceived Stress Scale (PSS-10) Scores
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Scores
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Profile of Mood States (POMS) Scores
Time frame: Baseline, Week 4, Week 8, Week 12
Change in Salivary Cortisol Awakening Response (CAR)
Time frame: Baseline and Week 12
Change in Bedtime Salivary Cortisol Levels
Time frame: Baseline and Week 12
Change in Liver Function Test Parameters (ALT, AST, ALP, Bilirubin)
Time frame: Baseline and Week 12
Change in Renal Function Test Parameters (Serum Creatinine, BUN)
Time frame: Baseline and Week 12
Change in Thyroid Function Test Parameters (T3, T4, TSH)
Time frame: Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline, Week 4, Week 8, Week 12
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Baseline, Week 4, Week 8, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shatavari (Asparagus racemosus) Root Extract in people with Perimenopause and Women Health, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. John Ademola (415-845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menopause Rating Scale (MRS) Total Score (time frame: Baseline, Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.