CTRI/2012/05/002634招募中4 期
Open, randomized controlled study of the efficacy of Spirulina with higher phycocyanin in obese people with fatty liver
Parry Nutraceuticals0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
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
- •Inclusion Criteria
- •Volunteers shall meet all of the following inclusion criteria to be eligible for participation in this study:
- •1.Male and female patients of age greater than 18 and less than 65 years shall be selected.
- •2.BMI greater than or equal to 25 kg/m2 or Waist circumference for male greater than 90cm & female greater than 80 cm
- •3.Subjects fasting blood glucose level less than 120mg/dl.
- •4.Subjects Blood Pressure should be between 110-139/70-89mm hg with or without treatment.
- •5.Triglyceride greater than 150mg/dl.
- •6.Ultrasound finding showing fatty liver
- •7.Adult patients willing to give informed consent.
- •8.Subject must be available for and willing to attend all evaluation visits.
- •9.Subject must have access to telephone for calling into the clinical center as part of test product compliance or be willing and able to fill in a daily dairy for clinical review.
排除标准
- •Exclusion Criteria
- •1.Patients suffering from Diabetes mellitus
- •2.Subjects below the age of 18 years and above the age of 65 years
- •3.Subjects with BMI greater than 25 kg/m2
- •4.Chronic alcohol intake.
- •5.History of any drug abuse in the past 12 months.
- •6.History of hypersensitivity to study medications and related drugs or excipients in the formulation.
- •7.History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions.
- •8.History of Congestive Heart Failure
- •9.History of End Stage Renal Failure
- •10.Subject with uncontrolled hypertension
- •11.History of stroke
- •12.History of myocardial infarction
- •13.History of Unstable angina pectoris
- •14.Subjects who are under treatment with Glucocorticoids oestrogens tamoxifen amiodarone methotrexate diltiazem zidovudine valproate aspirintetracycline and cocaine.
- •15.Patient who is not willing to participate in the study
- •16.Clinically significant abnormal laboratory results at screening.
- •17.Subject is being treated for severe active infection of any type
- •18.A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
- •19.Subject with clinically relevant uncontrolled medical condition(e.g. hematologic renal hepatic neurologic cardiac or respiratory)
- •20.Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
- •21.Participating in a clinical research trial within 30 days prior to randomization
- •22.Individuals who are cognitively impaired and/or who are unable to give informed consent.
- •23.Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or that may pose significant risk to the subject.
- •The patients meeting any of the above criteria will be excluded from the study
研究者
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