A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Shevari4 On Health and Quality of Life in Premenopausal, Perimenopausal, And Postmenopausal Groups Healthy Women.

Cepham, INC3 个研究点分布在 1 个国家目标入组 120 人开始时间: 2025年2月17日最近更新: 2025年2月12日

试验速览

阶段: Unknown
状态: 招募中
发起方
入组人数: 120
试验地点: 3
主要终点: The primary objective of the study

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of Shevari4 On Health and Quality of Life in Premenopausal, Perimenopausal, And Postmenopausal Groups Healthy Women. To assess the efficacy of SheVari4 in Premenopausal, Perimenopausal, And Postmenopausal syndrome using MRS QoL Survey. The total planned study duration is 24 to 25 weeks, which includes an initial recruitment period of 3 weeks and follow-up period of 10-12 weeks and 3 weeks for site close out and statistical analysis respectively and 2 weeks for the final report. However, if the planned recruitment is not completed within the initial 6 months (24 to 25 weeks), the recruitment period will be prolonged until the planned recruitment is completed.

研究设计

研究类型: Observational

入排标准

年龄范围: 29.00 Year(s) 至 65.00 Year(s)（—）
性别: Female

入选标准

•Age between 29 and 65 years (inclusive).
•Body Mass Index of 18.5-29.9 (inclusive).
•Resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg
•Resting heart rate less than 90 per minute.
•Patients attained menopause.
•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
•Provide voluntarily signed and dated informed consent on paper.
•The language services in case of non-English will be provided.
•Be in good health as determined by medical history and routine blood chemistries.
•Willing to duplicate their previous 24-hour diet and fast for 10 hours prior to each visit.
•Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
•Subject willing and able to comply with the study protocol.

排除标准

•Current bladder dysfunction.
•Current bladder neck contracture or urethral structure.
•Current acute or chronic UTI.
•Use of any other herbal medications within the past month.
•History of radiotherapy.
•History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
•History of diabetes or endocrine disorder.
•History of use of medications or dietary supplements known to confound the study or its endpoints.
•Use of hormone replacement therapy, oral contraceptives, or other hormone treatment.
•Women who underwent a hysterectomy.
•Dietary consumption of soya containing foods.
•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.
•Current smokers or smoking within the past month.
•History of hyperparathyroidism or an untreated thyroid condition.
•History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
•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).
•Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohnâ€™s, ulcerative colitis, Lupus, HIV/AIDS, etc.).
•Known sensitivity to any ingredient in the test formulations as listed in the product label.
•Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
•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.