Recruiting

Shatavari

Sponsor:

India Glycols Ltd

Code:

NCT07834463

Conditions

Menopause

Hot Flashes

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

Interventions

Shatavari (Asparagus racemosus) Extract

Placebo

Study Details

Brief 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. 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.

Conditions

Menopause

Hot Flashes

Study ID

NCT07834463

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Shatavari Herbal Extract

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.

placebo comparator: Placebo

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.

Interventions

Shatavari (Asparagus racemosus) Extract

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.

Placebo

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.

Primary outcome measure

  • Change in Menopause Rating Scale (MRS) Total Score [ Time Frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days) ]
  • 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) ]

Central Contacts and Locations

Locations

MusB Research LLC

Recruiting

New Port Richey, Florida, United States, 34653

Contacts

MusB Diagnostics

8134190781info@musbdiagnostics.com

More Information

Sponsor

India Glycols Ltd

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Menopause
  • Postmenopausal women
  • Menopausal symptoms
  • Hot flashes
  • Vasomotor symptoms
  • Shatavari
  • Asparagus racemosus
  • Herbal extract
  • Sleep quality
  • Quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by India Glycols Ltd on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.