A prospective, randomized, double blind, three-arm, parallel group, placebo controlled clinical Study to evaluate the Efficacy and Safety of Garlixir TM capsules (250 and 500 mg) in hyperlipidemia patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- •Total Cholesterol Screening, Day 42, and Day 84 (End of the treatment).
研究概览
简要总结
A prospective, Randomized, Double blind , three arm , parallel Group, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Garlixir TM capsule (250 mg or 500 mg) in Hyperlipidemia Patients. The Main Objective of the study is to evaluate the Efficacy of Garlixir TM Capsule In Hyperlipidemia patients by evaluating the Changes in Laboratory parameters :- Total Cholestrol, LDL Cholestrol, And Triglycerides from Screening to EOT The secondary objective of the study is to Evaluate the safety of Garlixir TM capsule in Hyperlipidemia patients by recording the Incidence and rate of adverse events from Screening to EOT In this trial total number of subjects is 78 and they will be follow up for 12 weeks. The data will be analyzed with 5% significance level and 80% power for study using SAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •1.Patient meeting the requirements of any one of the following parameters:- .Total cholesterol (201-239 mg/dl), .LDL-C (130-159 mg/dl), .Triglycerides (161-230 mg/dl).
- •2.Patients willing to give a written informed consent along with audio video visual and willing to visit the site for a regular follow up.
- •3.Patients willing to abide by and comply with the study protocol requirements & restriction BMI (body mass index) 19-30 kg/m2 (42-66 lb/m2) 4.Patient should be non-alcoholic.
- •5.Patients willing to abstain from usage of any NSAIDs during the study duration 6.Patients willing to abstain from heavy exercise (Jogging, Weight lifting etc.) during the study duration.
排除标准
- •1.Patients with history or presence of .Any clinically significant Respiratory system disorders .Central nervous system disorders .Reproductive system disorders .Gastro intestinal disorders & having problems in swallowing or digesting.
- •.Diabetes (type I or II) or history of gestational diabetes .Heart disease .Active neoplasm’s .Renal or liver disease .Hyperthyroidism or Hypothyroidism 2.Patients who are pregnant, lactating or nursing.
- •3.Patients currently advised or are on lipid lowering medications (known to affect lipid metabolism, platelet function, or antioxidant status) 4.Patients currently advised or are on blood pressure medications.
- •5.Patient undergoing the following medications .Protease inhibitors (e.g., indinavir, saquinavir), non-nucleoside reverse transcriptase inhibitors (NNRTIs such as nevirapine, efavirenz), isoniazid, .Blood Thinners such as warfarin and heparin .Anti-platelet drugs such as Aspirin & clopidogrel .Calcium channel blockers including diltiazem .Azole antifungals including ketoconazole, Fluconazole etc .Medications with Garlic Supplements.
- •.Patients using oral contraceptives & Steroids.
- •.Patients smoking 20 or more cigarettes per day (Heavy smokers).
结局指标
主要结局
•Total Cholesterol Screening, Day 42, and Day 84 (End of the treatment).
时间窗: Screening, Day 42, and Day 84 (End of the treatment).
•LDL Cholesterol Screening, Day 42, and Day 84 (End of the treatment).
时间窗: Screening, Day 42, and Day 84 (End of the treatment).
•Triglycerides Screening, Day 42, and Day 84 (End of the treatment).
时间窗: Screening, Day 42, and Day 84 (End of the treatment).
次要结局
- •Incidence and rate of adverse events(Screening, Day 42, and Day 84 (End of the treatment).)