MenopauseRENEWNCT07834463
Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
A study testing Shatavari (Asparagus racemosus) Extract in people with Menopause and Hot Flashes, run by India Glycols Ltd at 1 site in United States.
Trial summary
This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women. The study will compare the herbal extract with a matching placebo. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Shatavari (Asparagus racemosus) Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Aug 2027
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects aged 45-60 years at screening.
- Post-menopausal status, defined as no menstrual period for at least 12 months, graded as post-menopausal per STRAW classification (not due to pregnancy, lactation, or medical/surgical causes).
- Menopause Rating Scale (MRS) score > 9 at screening.
- Average frequency of hot flashes >= 3 per day for at least 7 consecutive days prior to screening.
- Willing and able to provide written informed consent and comply with study procedures, including maintaining the daily hot-flash diary.
Who cannot join
- Body mass index (BMI) <= 18 kg/m2 or > 35 kg/m2.
- History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers.
- History of uterine resection or hysterectomy.
- Unexplained abnormal uterine bleeding occurring after >= 1 year of menopause.
- History of severe migraine, or diagnosis of thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or history of coronary angioplasty within 1 year prior to screening.
- Currently undergoing treatment for severe disease of the cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal/urologic, nervous, or musculoskeletal system, or for infectious disease or malignancy.
Show all 17Show fewer
- Psychiatric disorders: clinically diagnosed depression, anxiety disorder, or sleep disorder within 3 months prior to screening treated with medication, or current use of neuropsychiatric drugs.
- Use of thyroid hormones, clonidine, anticoagulants, antiplatelet agents (e.g., warfarin, clopidogrel), or osteoporosis treatments within 3 months prior to screening.
- Use of any medication or plant-based hormone-like extract for menopausal symptoms within 3 months prior to screening.
- Continuous intake of health functional foods related to menopause or herbal medicine within 1 month prior to screening.
- Uncontrolled hypertension (resting blood pressure >= 160/100 mmHg after 10 minutes of rest).
- Uncontrolled diabetes (fasting blood glucose >= 180 mg/dL or HbA1c > 9.5%).
- Excessive use of tobacco (>20 cigarettes/day), caffeine (>5 cups/day), or alcohol (>14 drinks/week) within 4 weeks prior to screening.
- History of clinically reported drug abuse within 1 year prior to screening.
- Known clinically significant hypersensitivity to any component or excipient of the investigational product.
- Participation in another interventional clinical trial within 1 month prior to study start.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation.
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, 1 recruiting
- Recruiting
MusB Research LLC
New Port Richey, Florida, 34653
MusB Diagnostics, 8134190781, info@musbdiagnostics.com
About this study
Official title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Herbal Extract With Natural Bio-Enhancer Additives on Menopausal Symptoms in Post-Menopausal Women
This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women. The study will compare the herbal extract with a matching placebo. Approximately 100 women aged 45 to 60 years with menopausal symptoms will be enrolled, with approximately 80 expected to complete the study. Participants will take one study product daily for 8 weeks. Menopausal symptoms, including hot flashes, mood, sleep, skin health, and hair and scalp health, will be assessed using questionnaires, a daily hot flash diary, blood tests, and safety assessments.
Read the detailed description
Menopause is associated with a range of symptoms that may substantially affect quality of life, including vasomotor symptoms such as hot flashes and night sweats, sleep disturbances, mood changes, and changes in skin and hair health. Although hormone therapy can be effective for menopausal symptoms, some women seek non-hormonal approaches.
This study is designed to evaluate a standardized herbal extract containing Shatavari with natural bio-enhancer ingredients as a potential non-hormonal approach for managing menopausal symptoms. The study will use a randomized, double-blind, placebo-controlled design to compare the test product with a matching placebo over an 8-week intervention period.
The primary evaluation will focus on changes in overall menopausal symptom burden and hot flash symptoms. Additional evaluations will examine depressive symptoms, sleep quality, self-reported skin health, and self-reported hair and scalp health. Safety and tolerability will also be monitored throughout the study.
Exploratory assessments will evaluate changes in selected inflammatory and hormonal biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), follicle-stimulating hormone (FSH), estradiol, and luteinizing hormone (LH). Changes in thigh and hip circumference will also be explored as anthropometric measures.
Participants will undergo screening, baseline/randomization, mid-study, and end-of-study assessments. Study-related information will be collected using validated questionnaires, participant diaries, laboratory assessments, vital signs, anthropometric measurements, and adverse-event monitoring. Participants will be followed for adherence to the study product and completion of study assessments.
- Conditions
- Menopause, Hot Flashes
- Being tested
- Shatavari (Asparagus racemosus) Extract, Placebo
- Keywords
- Menopause, Postmenopausal women, Menopausal symptoms, Hot flashes, Vasomotor symptoms, Shatavari, Asparagus racemosus, Herbal extract, Sleep quality, Quality of life
- Medical subject headings
- Hot Flashes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shatavari (Asparagus racemosus) ExtractDietary supplement
Also called Shatavari
Shatavari (Asparagus racemosus) extract provided as a 400 mg oral capsule containing Shatavari extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The intervention will be administered under double-blind conditions and compared with a matching placebo.
PlaceboOther
Matching placebo capsule formulated to match the active Shatavari study product in appearance and administration. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The placebo will contain no active Shatavari extract and will be used as the comparator under double-blind conditions.
| Study group | Role | What they receive |
|---|---|---|
| Shatavari Herbal Extract | Experimental | Participants assigned to this arm will receive one 400 mg study capsule orally once daily for 8 weeks. The study product contains Shatavari (Asparagus racemosus) extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide, with a total capsule weight of 400 mg. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes. Receives: Dietary Supplement: Shatavari (Asparagus racemosus) Extract |
| Placebo | Placebo comparator | Participants assigned to this arm will receive one matching placebo capsule orally once daily for 8 weeks. The placebo will be formulated to match the appearance and administration of the active study product. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes. Receives: Other: Placebo |
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
Change in menopausal symptom severity from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Menopause Rating Scale (MRS). The MRS consists of 11 items covering somatic, psychological, and urogenital menopausal symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms), with a total score ranging from 0 to 44. Higher scores indicate greater severity of menopausal symptoms. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Measured: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Average Daily Hot Flash Frequency
Change in average daily hot flash frequency from the baseline run-in period to the end of treatment. Hot flash frequency will be calculated as the mean number of hot flashes recorded per day during the 7-day baseline run-in period before Day 0 and during the assessment period at the end of treatment. A decrease in average daily hot flash frequency indicates improvement.
Measured: Baseline Run-in Period (7 days before Day 0) to End-of-Study Assessment (Day 56 ± 5 days)
Secondary outcomes (4)
Change in Beck Depression Inventory-II (BDI-II) Score
Change in depressive symptoms from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-report instrument assessing depressive symptoms. Each item is scored from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. A decrease in BDI-II score indicates improvement in depressive symptoms.
Measured: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Athens Insomnia Scale (AIS) Score
Change in sleep disturbance symptoms from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Athens Insomnia Scale (AIS). The AIS is an 8-item self-report scale assessing sleep difficulty and related daytime functioning. Each item is scored from 0 to 3, with a total score ranging from 0 to 24. Higher scores indicate greater severity of insomnia symptoms. A decrease in AIS score indicates improvement in sleep symptoms.
Measured: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Self-Reported Skin Radiance Score
Change in participant-reported skin radiance from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), assessed using the study-specific Participant-Reported Skin Health Questionnaire. Skin radiance is assessed using the predefined response scale in the questionnaire. Higher scores indicate better self-reported skin radiance.
Measured: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Hair & Scalp CARE Questionnaire Total Score
Change in participant-reported hair and scalp health from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), assessed using the Hair \& Scalp CARE questionnaire. The questionnaire contains 23 items assessing the psychological and functional impact of hair and scalp problems. Each item is scored using a 5-point response scale from 0 (Never) to 4 (All the time), with a total score ranging from 0 to 92. Higher scores indicate a greater impact of hair and scalp problems. A decrease in score indicates improvement.
Measured: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Sep 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- India Glycols Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834463
- Sponsor's protocol ID
- IRB#26-008
- Acronym
- RENEW
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1) What's Happening and How to Manage It. Journal of Primary Care Community Health 61(3), 2) Menopause symptoms and their management. Endocrinol Metab Clin North Am 2015 Sep 3) Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am 2011 Sep 4) Risks and benefits of hormone replacement therapy: the evidence speaks. CMAJ. 2003 Apr 15;168(8):1001-10. 5) Colloidal and vesicular delivery system for herbal bioactive constituents. Daru. 2021 Dec 6) Electron Physician 2017 Nov 25 7) Women's Self-Assessment of Quality of Life and Menopausal Symptoms: An Online Survey of 26,000 Women in German-Speaking Countries. Int J Environ Res Public Health. 2025 Sep 30 8) Evaluating the Effects of Symptom Monitoring on Menopausal Health Outcomes: A Systematic Review and Meta-Analysis. Front Glob Womens Health. 2021 Dec 3 9) Heinemann K, Ruebig A, Potthoff P, Schneider HPG, Strelow F, Heinemann LAJ and Thai Do M.(2004). Health Qual Life Outcomes. 2004 Sep 2 10) Islam RM, Rana J, Rana J, and Davis SR.(2025). Exploring heterogeneity in the associations between menopausal status and depression: a cross-sectional study with a unique analytical approach. Menopause 2025 May 1 11) Instruments to study sleep disorders in climacteric women.Sleep Sci 2016 Jul-Sep;9 12) Lack of herbal supplement characterization in published randomized controlled trials. Am J Med 200 Oct;118(10)
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Herbal Extract With Natural Bio-Enhancer Additives on Menopausal Symptoms in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT07834463
- Acronym / sponsor ID
- RENEW / IRB#26-008
- Conditions
- Menopause, Hot Flashes
- Keywords
- Menopause, Postmenopausal women, Menopausal symptoms, Hot flashes, Vasomotor symptoms, Shatavari, Asparagus racemosus, Herbal extract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- India Glycols LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Sep 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 study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women. The study will compare the herbal extract with a matching placebo. Approximately 100 women aged 45 to 60 years with menopausal symptoms will be enrolled, with approximately 80 expected to complete the study. Participants will take one study product daily for 8 weeks. Menopausal symptoms, including hot flashes, mood, sleep, skin health, and hair and scalp health, will be assessed using questionnaires, a daily hot flash diary, blood tests, and safety assessments.
Detailed description
Menopause is associated with a range of symptoms that may substantially affect quality of life, including vasomotor symptoms such as hot flashes and night sweats, sleep disturbances, mood changes, and changes in skin and hair health. Although hormone therapy can be effective for menopausal symptoms, some women seek non-hormonal approaches.
This study is designed to evaluate a standardized herbal extract containing Shatavari with natural bio-enhancer ingredients as a potential non-hormonal approach for managing menopausal symptoms. The study will use a randomized, double-blind, placebo-controlled design to compare the test product with a matching placebo over an 8-week intervention period.
The primary evaluation will focus on changes in overall menopausal symptom burden and hot flash symptoms. Additional evaluations will examine depressive symptoms, sleep quality, self-reported skin health, and self-reported hair and scalp health. Safety and tolerability will also be monitored throughout the study.
Exploratory assessments will evaluate changes in selected inflammatory and hormonal biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), follicle-stimulating hormone (FSH), estradiol, and luteinizing hormone (LH). Changes in thigh and hip circumference will also be explored as anthropometric measures.
Participants will undergo screening, baseline/randomization, mid-study, and end-of-study assessments. Study-related information will be collected using validated questionnaires, participant diaries, laboratory assessments, vital signs, anthropometric measurements, and adverse-event monitoring. Participants will be followed for adherence to the study product and completion of study assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shatavari Herbal Extract | Experimental | Dietary Supplement: Shatavari (Asparagus racemosus) ExtractParticipants assigned to this arm will receive one 400 mg study capsule orally once daily for 8 weeks. The study product contains Shatavari (Asparagus racemosus) extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide, with a total capsule weight of 400 mg. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes. |
| Placebo | Placebo comparator | Other: PlaceboParticipants assigned to this arm will receive one matching placebo capsule orally once daily for 8 weeks. The placebo will be formulated to match the appearance and administration of the active study product. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects aged 45-60 years at screening.
- Post-menopausal status, defined as no menstrual period for at least 12 months, graded as post-menopausal per STRAW classification (not due to pregnancy, lactation, or medical/surgical causes).
- Menopause Rating Scale (MRS) score > 9 at screening.
- Average frequency of hot flashes >= 3 per day for at least 7 consecutive days prior to screening.
- Willing and able to provide written informed consent and comply with study procedures, including maintaining the daily hot-flash diary.
Key exclusion criteria (17 listed)
- Body mass index (BMI) <= 18 kg/m2 or > 35 kg/m2.
- History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers.
- History of uterine resection or hysterectomy.
- Unexplained abnormal uterine bleeding occurring after >= 1 year of menopause.
- History of severe migraine, or diagnosis of thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or history of coronary angioplasty within 1 year prior to screening.
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) ExtractAlso: ShatavariShatavari (Asparagus racemosus) extract provided as a 400 mg oral capsule containing Shatavari extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The intervention will be administered under double-blind conditions and compared with a matching placebo. | Dietary supplement | Shatavari Herbal Extract |
| PlaceboMatching placebo capsule formulated to match the active Shatavari study product in appearance and administration. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The placebo will contain no active Shatavari extract and will be used as the comparator under double-blind conditions. | Other | Placebo |
Primary outcome
Change in Menopause Rating Scale (MRS) Total Score
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in menopausal symptom severity from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Menopause Rating Scale (MRS). The MRS consists of 11 items covering somatic, psychological, and urogenital menopausal symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms), with a total score ranging from 0 to 44. Higher scores indicate greater severity of menopausal symptoms. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Change in Average Daily Hot Flash Frequency
Time frame: Baseline Run-in Period (7 days before Day 0) to End-of-Study Assessment (Day 56 ± 5 days)
Change in average daily hot flash frequency from the baseline run-in period to the end of treatment. Hot flash frequency will be calculated as the mean number of hot flashes recorded per day during the 7-day baseline run-in period before Day 0 and during the assessment period at the end of treatment. A decrease in average daily hot flash frequency indicates improvement.
4 secondary outcomes
Change in Beck Depression Inventory-II (BDI-II) Score
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Athens Insomnia Scale (AIS) Score
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Self-Reported Skin Radiance Score
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Change in Hair & Scalp CARE Questionnaire Total Score
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
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 22 Sep 2026.
- Results publication1) What's Happening and How to Manage It. Journal of Primary Care Community Health 61(3), 2) Menopause symptoms and their management. Endocrinol Metab Clin North Am 2015 Sep 3) Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am 2011 Sep 4) Risks and benefits of hormone replacement therapy: the evidence speaks. CMAJ. 2003 Apr 15;168(8):1001-10. 5) Colloidal and vesicular delivery system for herbal bioactive constituents. Daru. 2021 Dec 6) Electron Physician 2017 Nov 25 7) Women's Self-Assessment of Quality of Life and Menopausal Symptoms: An Online Survey of 26,000 Women in German-Speaking Countries. Int J Environ Res Public Health. 2025 Sep 30 8) Evaluating the Effects of Symptom Monitoring on Menopausal Health Outcomes: A Systematic Review and Meta-Analysis. Front Glob Womens Health. 2021 Dec 3 9) Heinemann K, Ruebig A, Potthoff P, Schneider HPG, Strelow F, Heinemann LAJ and Thai Do M.(2004). Health Qual Life Outcomes. 2004 Sep 2 10) Islam RM, Rana J, Rana J, and Davis SR.(2025). Exploring heterogeneity in the associations between menopausal status and depression: a cross-sectional study with a unique analytical approach. Menopause 2025 May 1 11) Instruments to study sleep disorders in climacteric women.Sleep Sci 2016 Jul-Sep;9 12) Lack of herbal supplement characterization in published randomized controlled trials. Am J Med 200 Oct;118(10)
- Related InfoLink provided by the sponsor.
- 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) Extract in people with Menopause and Hot Flashes, run by India Glycols Ltd 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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 22 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 (Day 0) to End of Study (Day 56 ± 5 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07834463, which also lists 1 linked publication.
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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.