Effect of Ayush SR on psychological status and quality of life of apparently healthy elderly population – A multicenter double blind placebo controlled study

Ministry of Tribal Affairs0 个研究点目标入组 360 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•i.Apparently healthy elderly participants of age between 60 to 75 years of any sex,
•ii.Participants who are clinically stable with or without medication
•iii.Participants are willing to provide written informed consent for their participation in the study for 3 months.
•iv.Participants scoring 5 or more in Katz Index of Independence in Activities of Daily Living

•I.Known cases of uncontrolled Hypertension. (Average BP= 160/100 mm of Hg), uncontrolled Diabetes mellitus (HbA1c > 8%), uncontrolled Hypothyroidism with or without medication (S. TSH >10mIU/ml), severe cardiac dysfunction or Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit), renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),, Pulmonary Dysfunction (Asthmatic and COPD patients) and any severe cognitive or psychiatric illness, neurological disorders, hemorrhagic problems, coagulation, or bleeding issues within 90 days prior to the screening
•II.Participants having body mass index (BMI) less than 22 or more than 32 kg/m2
•III.Participants with a history of cancer or chronic inflammatory conditions, including but not limited to chronic infection like tuberculosis, leprosy, HIV, and collagen vascular diseases
•IV.Participants on hormone replacement therapy, steroid therapy, chemotherapy, or immunosuppressive therapy
•V.Participants with alcohol use disorder (AUD) (CAGE score >2)
•VI.Any other condition that PI may think can jeopardize the study.

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