An interventional study of Shatavari (Asparagus racemosus) Extract and Placebo in Menopause and Hot Flashes, sponsored by India Glycols Ltd. Recruiting at 1 site in United States. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by India Glycols Ltd · Not applicable, Interventional, and Treatment
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.
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →This is the only study on the registry with India Glycols Ltd as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Shatavari (Asparagus racemosus) Extract
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.
Other: Placebo
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.
Also known as: Shatavari
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.
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.
Time frame: 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.
Time frame: Baseline Run-in Period (7 days before Day 0) to End-of-Study Assessment (Day 56 ± 5 days)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days)
Plan to share: No
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Studies of the drug tested here: Asparagus racemosus