An open-label, parallel-group study to evaluate the safety and efficacy of investigational products in adults with newly diagnosed dyslipidemia.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Tilman SA
- 入组人数
- 225
- 试验地点
- 4
- 主要终点
- 1. Assessment of changes in fasting lipid parameters including total cholesterol (TC), low-density lipoprotein cholesterol (LDL), very
研究概览
简要总结
Dyslipidemia, characterized by elevated total cholesterol, LDL-C, triglycerides, or low HDLC,
is a major global public health concern and a key contributor to cardiovascular disease, the
leading cause of mortality worldwide. Despite the availability of pharmacotherapies such
as statins, fibrates, and PCSK9 inhibitors, challenges persist due to statin intolerance,
incomplete lipid control, and adverse effects, which limit optimal therapy adherence.
Moreover, a significant proportion of adults with dyslipidemia remain untreated or
uncontrolled, highlighting the need for alternative or complementary treatment approaches
.
Herbal and nutraceutical formulations, including extracts from amla, berberis, pomegranate,
citrus, red yeast rice, urolithins, and flavonoids such as hesperidin, have demonstrated
potential lipid-lowering, antioxidant, and anti-inflammatory effects in preclinical and clinical
studies, often with favorable safety profiles. However, evidence from well-designed,
controlled clinical trials evaluating their efficacy and safety in adults with newly diagnosed
dyslipidemia remains limited.
This study is therefore designed to evaluate the efficacy, safety, and tolerability of multiple
investigational herbal and nutraceutical combinations on fasting lipid parameters,
anthropometric measures, subjective symptom scores, and metabolic state over a 60-day
treatment period in adults with newly diagnosed dyslipidemia. The findings aim to provide
robust clinical data supporting the use of these formulations as potential adjuncts or
alternatives to conventional lipid-lowering therapies.
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
- •Male and females aged 30-60 years (both inclusive);
- •Clinically diagnosed with dyslipidemia in past 3 months, must exhibit specific fasting lipid profiles, meeting the following thresholds: 1.Fasting total cholesterol concentration greater than or equal to 200 mg/dL 2.Fasting triglyceride concentration.
- •150 to 499 mg/dL 3.Fasting LDL-cholesterol concentration.
- •greater than or equal to 130 to less than or equal to 189 mg/dL
- •Participants without concomitant statin therapy (treatment naïve)
- •Willing and able to follow dietary and lifestyle recommendations
- •Participants with BMI 18.5-30 kg/m2at screening
- •Participants providing voluntary, written informed consent to participate in the study.
排除标准
- •Known or suspected allergy/hypersensitivity to any component of the investigational product.
- •Any other cardio-diabetic comorbidity as per investigators discretion.
- •Difficulty sleeping due to a medical condition.
- •History of a neurological disorder.
- •History of bipolar disorder, psychotic disorder, posttraumatic stress disorder, or current psychiatric disorder that requires medication.
- •Ongoing clinical depression and anxiety disorder (showing moderate to severe diagnosis on Participants Health Questionnaire-9 (PHQ 9) and Generalized Anxiety Disorder-7 (GAD 7) scales).
- •History of substance abuse or dependence.
- •History or current evidence of a clinically significant cardiovascular disorder at pre study visit.
- •Taking certain prohibited medications.
- •Consumption of more than 15 cigarettes a day.
- •History of malignancy less than or equal to 5 years prior to signing an informed consent.
- •Participants on medication that may interfere lipid metabolism.
- •Participants consuming nutraceuticals and health supplements for past three months.
- •Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
1. Assessment of changes in fasting lipid parameters including total cholesterol (TC), low-density lipoprotein cholesterol (LDL), very
时间窗: baseline, day 30, and day 60.
low-density lipoprotein cholesterol (VLDL-C), triglycerides (TG), high-density lipoprotein cholesterol (HDL), and remnant cholesterol
时间窗: baseline, day 30, and day 60.
(RC)
时间窗: baseline, day 30, and day 60.
次要结局
- 1. Assessment of changes in subjective symptom scores (fatigue, joint pain, muscle pain, sweating, lethargy, weakness, exertional dyspnea) using a visual analog scale (VAS) scale.(at baseline, day 30, and day 60.)
- 2. Assessment of change in Body weight, BMI, waist and hip circumference.(at baseline, day 30, and day 60.)
- 3. Assessment of changes in metabolic state (MetS-Z score)(at baseline, day 30, and day 60.)
- Exploratory endpoint(Change in oxidized LDL (ox-LDL) levels in selected treatment groups)
研究者
Dr Ramshyam Agarwal
Health Nexus Medical Research