CTRI/2024/07/069846尚未招募2 期
Evaluation of safety and efficacy of nutritional product in patients with dyslipidemia.
Life Synergy1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年7月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1.Assessment of changes in fasting lipid parameters (total cholesterol, LDL, VLDL, triglycerides, HDL).
研究概览
简要总结
The current study aims to investigate the potential of nutritional supplement in the management of high cholesterol and related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1.Assessment of changes in fasting lipid parameters (total cholesterol, LDL, VLDL, triglycerides, HDL).
时间窗: From Screening to end of the study.
2.Assessment of changes in biomarkers like hs-CRP, Apolipoprotein A, B, and creatine kinase.
时间窗: From Screening to end of the study.
次要结局
- 1.Incidence and severity of adverse events.(2.Changes in anthropometric parameters like body weight, BMI, waist circumference.)
研究者
Dr Amol Gothwad
Lokmanya Medical Research Centre and Hospital
研究点 (1)
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