None listed
Conditions
Interventions
Intervention1: Shevari 100mg Capsule made from Asparagus racemosus Root Ethanol Extract 5% Shatavarin IV: Dose - 100mg capsule
Frequency - Once a day with evening meal
Total Duration - 6 Weeks
Control Intervention1: Placebo 110mg Capsule made up of Brown Rice Starch: Dose - 100mg capsule
Total Duration - 6 Weeks
Sponsors
Cepham, INC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 29 and 65 years (inclusive). 2. Body Mass Index of 18.5-29.9 (inclusive). 3. Resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg 4. Resting heart rate less than 90 per minute. 5. Patients attained menopause. 6. Gynaecological examination will be done at the screening. The pap smear test and sonography will be done to rule out Gynaecological issues to declare the patient fit at the discretion of the Principal Investigator 7. Provide voluntarily signed and dated informed consent on paper. 8. The language services in case of non-English will be provided. 9. Be in good health as determined by medical history and routine blood chemistries. 10. Willing to duplicate their previous 24-hour diet and fast for 10 hours prior to each visit. 11. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period. 12. Subject willing and able to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Current bladder dysfunction. 2. Current bladder neck contracture or urethral structure. 3. Current acute or chronic UTI. 4. History of breast, uterine, ovarian, and cervical cancers. 5. Use of any other herbal medications within the past month. 6. History of radiotherapy. 7. History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions. 8. History of diabetes or endocrine disorder. 9. History of use of medications or dietary supplements known to confound the study or its endpoints. 10. Use of hormone replacement therapy, oral contraceptives, or other hormone treatment. 11. Women who underwent a hysterectomy. 12. Dietary consumption of soya containing foods. 13. Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months. 14. Current smokers or smoking within the past month. 15. History of hyperparathyroidism or an untreated thyroid condition. 16. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin). 17. Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU). 18. Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn’s, ulcerative colitis, Lupus, HIV/AIDS, etc.). 19. Known sensitivity to any ingredient in the test formulations as listed in the product label. 20. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days. 21. Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study To assess the efficacy of SheVari4 in Premenopausal, Perimenopausal, And Postmenopausal syndrome using MRS QoL Survey. The primary endpoints of the study - MRS is composed of 11 items and divided into three subscales, Somatic Psychological Urogenital symptoms. The severity of symptoms varies from none, mild, moderate, and severe. The findings will be subjected to analysis before, after treatment, and follow-up using MRS scale. Timepoint: Day 1, Day 14, Day 28, Day 42, Day 56 and Day 70 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study as follows Change in hormone levels. Changes in blood biochemistry [comprehensive metabolic panel (CMP), liver function test, complete blood count (CBC)]. Changes in the weight & blood pressure. To assess the safety & tolerability The secondary endpoints as follows Measurement of Thyroxine, TSH, Prolactin, LH, FSH, Serum oestradiol. Measurement of CBC (HB, RBC Measurements, TC, DC & platelet count), Random blood sugar, Comprehensive metabolic panel (alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, blood urea nitrogen (BUN), creatinine, sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, & calcium). Changes in the weight & blood pressure. To record any adverse events Timepoint: Day 1, Day 14, Day 28, Day 42, Day 56 & Day 70 | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt. Ltd.
Outcome results
None listed