CTRI/2024/10/074541尚未招募4 期
A comparative evaluation of safety and efficacy of Rosuvastatin with and without Zinc as an adjuvant in pharmacotherapy of dyslipidemia in tertiary care Hospital, Kanpur (U.P)
Mahima Singh1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2024年10月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Efficacy in achieving target LDL-C and triglyceride levels
研究概览
简要总结
This study is a randomized, open labeled, parallel group, single- centre trial comparing the efficacy and safety of rosuvastatin 10 mg daily with and without zinc25mg for 12 weeks in 410 patients with Dyslipidemia that will be conducted in a tertiary care hospital, Kanpur, India. The primary outcome measures will be achieving target lipid profile during 6 weeks and 12 weeks of study period. The secondary outcomes will be evaluation of baseline data characterization, HDL-C variation, adverse events and patient compliance of the treatment at 6 and 12 weeks of study period.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having serum LDL cholesterol above 130mg/dl, Serum triglycerides above or equal to 150mg/dl and less than or equal to 500mg/dl.
- •Patients who are able to adequately maintain diary.
- •Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved ICF.
排除标准
- •Fasting serum triglyceride (TG) level above 500 mg/dl, Medical history of systemic infection within 6 weeks of study initiation, Medical history of unstable angina, myocardial infarction, heart failure or stroke within 3 months of the study, Uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 100 mm Hg), Uncontrolled diabetes mellitus (FBS above 300 mg/dl in patients with diabetes), ALT and AST greater than 2x upper limit of normal, Impaired renal function (creatinine greater than or equal to 2.0 mg/dl), Suffering from malabsorption syndrome or inflammatory bowel disease, Pregnancy/Lactation, Alcoholism, Patients on drugs that can increase the incidence of statin induced myopathy, Patient on chronic anti-inflammatory or antioxidant drugs within 6 weeks of study initiation.
结局指标
主要结局
Efficacy in achieving target LDL-C and triglyceride levels
时间窗: 6 and 12 weeks
次要结局
- To establish the patient characteristics based upon baseline data with dyslipidemia in Kanpur, UP population(Incidence of any adverse drug reaction will be reported at Timepoints-every 2 week for12 weeks)
研究者
Mahima Singh
RAMA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER
研究点 (1)
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