Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
Intervention1: Shatavari Root Extract Capsule 150 mg: Take one capsule once a day orally after breakfast for 2 months.
Intervention2: Shatavari Root Extract Capsule 400 mg: Take one capsule once a day
Sponsors
India Glycols Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meets at least one of the following: a. Postmenopausal b. Perimenopausal 2.Provided written informed consent and agreed to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1.BMI less than or equal to 18 kg per m2 or more than 30 kg per m2. 2.History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers. 3.History of uterine resection or hysterectomy. 4.Unexplained abnormal uterine bleeding occurring after 1 year of menopause. 5.History of severe migraine, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty within 1 year. 6.Currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal or hepatobiliary, renal or urologic, nervous, musculoskeletal, infectious, or malignant disease (except cancer survivors in complete remission for greater than or equal to 5 years, excluding endometrial, breast, or hormone-related cancers). 7.Subjects diagnosed with depression, anxiety disorder, or sleep disorder treated with medication, or currently taking neuropsychiatric drugs. 8.Use of thyroid hormones, clonidine, anticoagulants, antiplatelet agents (e.g., warfarin, clopidogrel), or osteoporosis therapy (selective estrogen receptor modulators [SERMs], bisphosphonates, etc.) 9.Use of any medication for menopausal symptoms (e.g., female hormone therapy or hormone analogs including plant extracts). 10.Continuous intake of health functional foods related to menopause, blood circulation, blood lipids, or joint or bone health (e.g., pomegranate, Cynanchum wilfordii, Schisandra chinensis, red ginseng, etc.), or continuous intake of herbal medicine. 11.Uncontrolled hypertension (resting blood pressure greater than or equal to 160 per 100 mmHg, measured after 10 minutes of rest). 12.Uncontrolled diabetes (fasting blood glucose greater than or equal to 180 mg per dL, or initiation of a new anti-diabetic medication within 3 months prior to screening). 13.AST or ALT less than 3 into upper limit of normal, Serum creatinine less than 2.0 mg per dL, TSH less than 0.1 mu U per mL or greater than 10 mu U per mL (uncontrolled thyroid dysfunction). 14.Excessive use of tobacco, caffeine, or alcohol within 4 weeks prior to screening (defined as caffeine more than 5 cups per day, alcohol greater than 14 drinks per week, smoking greater than 20 cigarettes per day). 15.History of drug abuse within 1 year prior to screening. 16.Known clinically significant hypersensitivity to any ingredient or excipient of the test item.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in Menopause Rating Scale (MRS) total score. Timepoint: Baseline and EOT ;Change in Beck Depression Inventory-II (BDI-II) total score.Timepoint: Baseline and EOT;Change in Athens Insomnia Scale (AIS) total score.Timepoint: Baseline and EOT;Change in bone turnover markers (bone-specific alkaline phosphatase [BSALP], C-terminal telopeptide [CTx]Timepoint: Baseline and EOT;Change in cardiovascular markers (nitric oxide [NO])Timepoint: Baseline and EOT;Change in lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol)Timepoint: Baseline and EOT;AEsTimepoint: Throughout the study;Change in Clinical laboratory testsTimepoint: Baseline and EOT;Change in vital signsTimepoint: Baseline and EOT;Change in hormonal assessmentTimepoint: Baseline and EOT;Change in endometrial thicknessTimepoint: Baseline and EOT;Change in mammographic densityTimepoint: Baseline and EOT | — |
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Modified Kupperman Index (mKI) total score. 2.Change in hot flash scoreTimepoint: 1.Baseline and EOT 2.Baseline and EOT | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.
Outcome results
None listed