CTRI/2024/06/069224尚未招募2 期
Clinical validation of polyherbal supplementation along with an AI- based tool for improving lifestyle in modulating stress, sleep, energy levels, and metabolic parameters in middle-aged women. - NI
Swiss Econaturals AG.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Females between the ages of 40-55 years (Both inclusive);2.Body Mass Index (BMI) between 19 and 30 kg/m²;3.No history of clinically relevant premenstrual syndrome (PMS);4.Willingness to complete questionnaires, records, and diaries associated with the study and to complete all visits;5.Provided voluntary, written informed consent to participate in the study;6.Participants should be willing to comply with the study protocol and follow prescribed lifestyle changes and supplementation regimens;7.Participants not consuming any health supplement and those willing to stop vitamin and other nutraceutical supplements and undergo washout period.
排除标准
- •1.Participants with a history of cardiovascular disease, including stroke, myocardial infarction, or unstable angina;
- •2.Participants with uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg);
- •3.Participants with diagnosed diabetes mellitus (fasting blood glucose greater than or equal to 126 mg/dL);
- •4.Participants with diagnosed thyroid disorders or endocrine disorders requiring ongoing treatment;
- •5.Participants with severe dyslipidemia (extremely elevated total cholesterol, LDL, triglycerides, or very low HDL levels);
- •6.Participants with a history of psychiatric disorders or conditions that may interfere with study participation or compliance;
- •7.Participants with chronic kidney disease or liver disease;
- •8.Participants with a history of or active cancer or undergoing cancer treatment;
- •9.Participants using medications or supplements that may interfere with the study interventions or assessments;
- •10.Participants who have participated in another clinical trial within the last 30 days;
- •11.Participantswithknownallergyor hypersensitivityto any components of the investigational products;
- •12.Pregnant and/or lactating women.
研究者
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