A double-blind, randomized placebo-controlled trial of individualized homeopathic medicines in the treatment of dyslipidaemia in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood LDL cholesterol level (LDL-C)
研究概览
简要总结
Dyslipidemias, in particular increased plasma LDL-cholesterol levels, are important risk factors for cardiovascular disease. Primary or family dyslipidemias are genetically determined, but secondary dyslipidemias are more frequently caused by other illnesses including diabetes mellitus, obesity, or an unhealthy lifestyle. The most prevalent kind of dyslipidaemia, hypercholesterolemia, is linked to a higher risk of cardiovascular disease. In 1990, raised plasma LDL-cholesterol levels were the 15th most important risk factor for death; by 2007, that number had risen to 11th, and by 2019, it had risen to the eighth. Previous research on the role of homoeopathic medicines in the treatment of dyslipidaemia offers promising yet inconclusive findings. Under such circumstances, we will intend to undertake this research project to ascertain the probable efficacy of Individualized Homoeopathic Medicines in comparison to placebo. This prospective, double blind, randomized, parallel-arm, placebo-controlled trial will be conducted on 100 adults suffering from Dyslipidaemia, and will be randomized in a 2:1 allocation ratio, following one of the two interventions i.e. Individualized Homoeopathic Medicines or identical-looking placebo, in the mutual context of concomitant care at the outpatient departments of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure is blood lipid profile (i.e. serum LDL- Cholesterol level), will be measured at baseline and after 3 months of treatment. Secondary outcome measures are blood lipid profile (i.e. TGs, Total cholesterol, VLDL-C, HDL-C), fasting blood sugar, post prandial blood sugar, 12 items short form questionnaire (SF-12). Lipid profile will be measured at baseline and after 3 months of treatment. SF-12 will be measured at baseline and every follow-up up to 3 months of intervention. Comparative analysis will be carried out on Intention to Treat (ITT) and Per protocol (PP) basis to detect group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient suffering from newly diagnosed cases of dyslipidaemia with LDL-C levels of 100-189mg/dl
- •Framingham risk score less than 20%
- •Age between 18 and 65 years.
- •Participants of either sex or transgender.
排除标准
- •Patients not providing with written informed consent of participation.
- •Familial hypertriglyceridemia.
- •Person already taking lipid lowering agents.
- •History of myocardial infarction, stenting, coronary artery bypass surgery or stroke.
- •Pregnant, puerperal, and lactating women.
- •Non ambulatory patients
- •Undergoing homoeopathic treatment for any chronic disease within the last 6 months
- •Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, diagnosed cases of unstable mental or psychiatric illness and self-reported immune-compromised state.
- •Uncontrolled hypertension, uncontrolled diabetes, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases or any other uncontrolled systemic diseases affecting the quality of life or organ failure.
- •Habits of tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence (TAPS tool)
- •Simultaneous participation in any other clinical trials.
结局指标
主要结局
Blood LDL cholesterol level (LDL-C)
时间窗: At baseline, and after 3 months
次要结局
- total cholesterol (TC),Triglycerides(TGs),HDL,VLDL,FBS,PPBS and liver enzymes (AST and ALT)(At baseline, and after 3 months)
- Short form 12(SF-12) health survey questionnaire(At baseline, monthly, up to 3 months)
研究者
Greeshma Raj K P
D. N. De Homoeopathic Medical College and Hospital