CTRI/2023/11/059395尚未招募1 期
Clinical evaluation of attributes of Withania somnifera extract in promoting healthy aging in elderly adults- A randomized, double-blind, placebo-controlled clinical trial. - NI
Phytoveda Pvt. Ltd.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
- 1 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
- •Patients meeting all of the following criteria will be eligible for the study:1. Male and females between 50-70 years of age (both inclusive);2. Patients with or without comorbidity. If comorbidity is present, it should be either one or both of the following:• In the case of type 2 diabetes, a hemoglobin A1c (HbA1c) level should be less than or equal to 8% on a stable regimen (i.e., same drug and same dose) for at least 12 weeks before the screening visit.• In the case of hypertension, systolic BP should be between 120 to 160 mm Hg (both inclusive), and diastolic BP should be between 70 to 100 mm Hg (both inclusive) while on a stable regimen (i.e., the same drug and same dose) for at least 12 weeks before the screening visit.3. Provided voluntary, written informed consent to participate in the study.4. Participants are able to read and write in English.
排除标准
- •Patients meeting any of the following criteria will not be eligible for the study
- •1.Known hypersensitivity to any components of an investigational medicinal product
- •2.Pregnant and/or lactating women
- •3.History or presence of malignancy within the last 2 years
- •4.Known case of asthma, uncontrolled diabetes mellitus, or hypertension
- •5.Participants on immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days before the start of the study
- •6.Any history or immediate family history of schizophrenia other psychotic or neurological illness severe personality disorder or other significant psychiatric disorder that the investigator believes could impact the participants ability to comply with study requirements
- •7.Patients having deranged biochemical parameters at screening
- •a). AST (SGOT), ALT (SGPT) greater than 1.5 x ULN (Upper Limit of Normal)
- •b). Total bilirubin greater than1.5 mg/dL
- •c). Creatinine greater than 2 mg/dL
- •d). Alkaline phosphatase greater than 5 x ULN.
- •8.Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, use of an illicit drug, or non-prescribed use of any prescription drug
- •9.Abnormal findings on ECG or chest X-ray as per the discretion of the investigator;
- •10.According to the investigator any other illness or abnormal laboratory investigations would interfere directly with the study results or jeopardize the participants health.
- •11.Participants who are currently using ashwagandha in any form
- •12.Participants who are taking any herbal nutraceutical supplements.
研究者
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