Dose-response Study of the Efficacy and Safety of Carduus Marianus in Centesimal Scale for Dyslipidemia in Overweighed or Obese Women in Peri- and Postmenopause: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change from baseline level of triglycerides at 4 and 8 weeks.
研究概览
简要总结
Metabolic disorders including hypercholesterolemia and hypertriglyceridemia are present in climacteric women. Carduus marianus is a homeopathic medicine that traditionally has been used for hepatic diseases. It has been used for reducing hypercholesterolemia and hypertriglyceridemia also. The aim of this study is to investigate the most effective dose of Carduus marianus in centesimal scale (6cH, 12cH, 30cH, placebo) plus diet and exercise for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.
详细描述
The prevalence of metabolic disorders including dyslipidemia increases as women transition from premenopause to postmenopause. This increases the risk for morbidity and mortality from cardiovascular diseases. Carduus marianus is a homeopathic medicine that traditionally has been used for hepatic diseases. Silymarin, isolated from Carduus marianus, owe its therapeutic and hepatoprotective effects to its strong antioxidant and anti-inflammatory properties. Carduus marianus is frequently used in clinical practice and reduces plasma level of triglycerides, total cholesterol and LDL in humans with dyslipidemia. Not all homeopaths agree on dosage and potency when prescribing homeopathic medicines. The aim of this study is to assess: (1) the most effective dose of Carduus marianus in centesimal scale for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women; (2) the effect of Carduus marianus in other metabolic parameters (glucose, glycosylated hemoglobin, insulin resistance, weight, body mass index, waist circumference).
This is a 8-week, double-blind, randomized, parallel, four-group, dose-response study to assess the safety and efficacy of Carduus marianus in 6cH, 12cH, 30cH and placebo plus diet and exercise, for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 40-65 years in early or late transition to menopause or postmenopause according to STRAW classification
- •hypertriglyceridemia [>150 <1000 mg/dL], and/or hypercholesterolemia [>200mg/dL]
- •overweight or obesity [BMI >25 Kg/m2]
- •fasting glucose <126mg/dL
- •glycosylated hemoglobin <6.5%
- •be willing and capable to follow study procedures.
排除标准
- •history of cardiovascular disease or coronary risk equivalents
- •secondary hyperlipidemia caused by diabetes mellitus, renal, liver or thyroid diseases
- •hypolipidemic agents, antidiabetic medication, hormone replacement therapy, tamoxifen, raloxifene, danazol, isotretinoin, acitretin, cyclosporin, azathioprine, protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), antipsychotics (clozapine), seizure medication (carbamazepine, valproic acid, phenobarbital, phenytoin) either on-going or any time in the previous 2 months
- •any other clinically significant illness that, in the opinion of the investigator, might put the patient at risk of harm during the study or might adversely affect the interpretation of the study data
- •pregnancy or breastfeeding.
研究组 & 干预措施
Diet + exercise + Carduus marianus 6cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 6cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Carduus marianus 6cH (Drug)
Diet + exercise + Carduus marianus 6cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 6cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Exercise (Behavioral)
Diet + exercise + Carduus marianus 6cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 6cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Diet (Other)
Diet + exercise + Carduus marianus 12cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 12cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Carduus marianus 12cH (Drug)
Diet + exercise + Carduus marianus 12cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 12cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Exercise (Behavioral)
Diet + exercise + Carduus marianus 12cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 12cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Diet (Other)
Diet + exercise + Carduus marianus 30cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 30c, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Carduus marianus 30cH (Drug)
Diet + exercise + Carduus marianus 30cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 30c, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Exercise (Behavioral)
Diet + exercise + Carduus marianus 30cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 30c, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Diet (Other)
Diet + exercise + placebo
Diet (1600 cal/day) + aerobic exercise (30 min daily) + placebo (87°alcohol), 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Placebo (Drug)
Diet + exercise + placebo
Diet (1600 cal/day) + aerobic exercise (30 min daily) + placebo (87°alcohol), 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Exercise (Behavioral)
Diet + exercise + placebo
Diet (1600 cal/day) + aerobic exercise (30 min daily) + placebo (87°alcohol), 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
干预措施: Diet (Other)
结局指标
主要结局
Change from baseline level of triglycerides at 4 and 8 weeks.
时间窗: 4 and 8 weeks after randomization
Change from baseline level of total cholesterol at 4 and 8 weeks.
时间窗: 4 and 8 weeks after randomization
次要结局
- Change from baseline level of LDL cholesterol at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline level of HDL cholesterol at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline level of fasting glucose at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline [HOMA-IR=insulin(mU/ml) X glucose (mg/dl)/405] at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline weight (kg) at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline body mass index (Kg/m2) at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Change from baseline waist circumference (cm) at 4 and 8 weeks.(4 and 8 weeks after randomization)
- Adverse events(8 weeks after randomization)
研究者
Emma del Carmen Macías-Cortés, PhD
Dr.
Hospital Nacional Homeopático, Mexico