Efficacy and Safety of KSM66 Ashwagandha (Withania somnifera) in Elderly for General health Improvement: A prospective, Randomized, Double-Blind, Placebo-Controlled Study

Ixoreal Biomed Private Limited0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1.Males and females aged between 60-85 years of age.
•2.ECOG Performance score 0 to 1.
•3.Body mass index (BMI) 22-32 kg/m2.
•4.Body weight =50 kg.
•5.Willing to comply with protocol and likely to be compliant with prescribed product.

•1.Known renal insufficiency or failure at screening.
•2.Current or previous positive documented history of any chronic inflammatory state including chronic infection like tuberculosis, leprosy, HIV etc., or collagen vascular disorder.
•3.Use of hormone replacement therapy (with the exception of levothyroxine).
•4.Uncontrolled hypertension [ > 140 Systolic and > 90 Diastolic].
•5.Uncontrolled diabetes mellitus [HbA1C >7%].
•6.Known hemorrhagic disorder and/or coagulation disorder, or clinically important bleeding within 90 days prior to screening visit.

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