CTRI/2020/10/028403已完成未知
A randomized, double-blind, placebo-controlled,parallel-group,multicentric clinical study to evaluate the efficacy and safety of test formulation on health of the elderly subjects.
ITC Life Sciences and Technology Centre0 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
- 未知
- 状态
- 已完成
- 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. Subjects with any one of the metabolic health risk factors
- •Dyslipidaemia( TG > 150 and < 199 mg/dL or
- •HDL Cholesterol < 40 mg/dL (in men) and < 50 mg/dL (in women) orLDL > 129 and < 159 mg/dL or
- •Total Cholesterol > 200 and < 240 mg/dL Not on statins) Diabetes(FBS: >= 126 mg/dL or PPBS: >= 200 mg/dL and Hb1Ac: > 6.5% On stable oral hypoglycaemic drugs since past three month) Hypertension(Controlled hypertension on stable hypertensive treatment since past 2 months)
- •BMI (>= 25.00 to < 29.9 kg/m2), Abdominal obesity( > 102 cm ( > 40 inch) in men and > 88 cm ( > 35 inch) in women
- •2.Subject meeting all the laboratory parameters set forth to qualify to enrol in the study
- •3. Pre-frail (score: 6-7) and Frail (score: 8-11) subjects as per Edmonton Frail Scale
- •4. Must be willing and able to give informed consent and comply with the study procedures
排除标准
- •1 Type 1 diabetes mellitus or secondary diabetes mellitus
- •2 Abnormal haematological or biochemical parameters other than specified in the inclusion criteria
- •3 Subjects who are on parental insulin, statins or any other lipid lowering drugs
- •4 Subjects on other therapies such as homeopathy / Ayurveda, naturopathy etc for treating above mentioned conditions
- •5 Subjects allergic to herbal products or any component of the study product
- •6 Known HIV or Hepatitis B positive or any other immuno-compromised state
- •7. History of Uncontrolled hypertension, Coronary artery disease, Angina, tread-mill test positive for inducible ischemia, Chronic metabolic disease, Psychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Bariatric surgery, Eating disorder such as bulimia or binge eating, Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery, Surgery of oesophagus, stomach or duodenum, Any acute gastrointestinal disorder within 2 weeks prior to study entry
- •8 Subjects having haemoglobin level <= 10 g/dL
- •9 Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude study participation
- •10 Non-Frail (score: 0-5) and severely frail (score: 12-17) subjects as per Edmonton Frail Scale
- •11 Currently participating or having participated in another clinical study during the last 3 months prior to the beginning of this study.
- •12 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
研究者
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