Evaluation of safety and efficacy of nutritional product in patients with dyslipidemia. - NI

ife Synergy0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1.Male and females aged 30 to 60 years both inclusive; 2.Clinically diagnosed with dyslipidemia, must exhibit specific fasting lipid profiles, meeting the following thresholds: 1.Fasting total cholesterol concentration 200 to 300 mg per dL 2.Fasting triglyceride concentration 150 to 250 mg per dL 3.Fasting LDL cholesterol concentration greater than 100 mg per dL 4.Fasting VLDL cholesterol concentration greater than 30 mg per dL 3.Participants with or without concomitant statin therapy; 4.Willing and able to follow dietary and lifestyle recommendations; 5.Participants with BMI 26 to 30 kg/m2 at screening; 6.Participants providing voluntary, written informed consent to participate in the study.

•1.Pregnancy or lactation,
•2.Presence of any significant comorbid condition like hypertension, diabetes,
•3.Unstable angina, myocardial infarction or stroke within 3 months,
•4.Body mass index (BMI) greater than 30 kg per meter square,
•5.Severe liver disease (Child Pugh Class C) or ALT AST more than 3 times upper limit of normal (ULN),
•6.Severe renal impairment (GFR less than 30 ml per min),
•7.History of cancer within 5 years (except non melanoma skin cancer),
•8.K C O uncontrolled hypothyroidism (TSH greater than 1.5 times ULN),
•9.Demyelinating disorders,
•10.Use of fibrates, niacin, fish oils or other lipid altering drugs,
•11.Known hypersensitivity to study drug components,
•12.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.

发起方

ife Synergy