CTRI/2020/10/028577尚未招募未知
A Randomized, Double-Blinded, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Efficacy and Safety of CLV 0025P at 250 mg/day in Subjects Having Metabolic Syndrome.
Akay Natural Ingredients Pvt Ltd0 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
- 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. Pre-diabetes subjects 30 (FBS: 100-125 mg/dL or PPBS: 140-199 mg/dL and Hb1Ac: 5.7â??6.4%)
- •2. Subjects with two or more of following metabolic health risk factors
- •Dyslipidaemia - TG > 150 mg/dL or
- •HDL Cholesterol < 40 mg/dL (in men) and < 50 mg/dL (in women)
- •Hypertension(Blood pressure >= 130 / 85 and
- •<140/90 mm Hg )
- •On stable hypertensive treatment since past 2 months
- •Overweight or obese (BMI >= 25 kg/m2 )
- •Abdominal obesity ( > 90 cm ( > 35 inch) in men and > 80 cm ( > 32 inch) in women )
- •3. Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
- •4.Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study
- •5.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Type 1 and 2 diabetes mellitus or secondary diabetes mellitus
- •2.Subjects having symptoms of viral infection, including COVID-19 infection
- •3.Abnormal haematological or biochemical parameters other than specified in the inclusion criteria
- •4.Subjects who are on parental insulin, statins or any other lipid lowering drugs
- •5.Subjects on other therapies such as homeopathy / Ayurveda etc for treating above mentioned conditions
- •6.Subjects allergic to herbal products or any component of the study product
- •7.Known HIV or Hepatitis B positive or any other immuno-compromised state
- •8.History of Uncontrolled hypertension, Coronary artery disease, Angina, tread mill test (TMT) positive for inducible ischemia, Chronic metabolic disease, Psychiatric illness, Drug abuse, smoking, abuse/addiction to alcohol, Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery, Surgery of oesophagus, stomach or duodenum, bariatric surgery Any acute gastrointestinal disorder within 2 weeks prior to study entry
- •9.Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation
- •10.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •11.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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