CTRI/2023/05/052246尚未招募2/3 期
A Prospective, Comparative, Open label Clinical Study to evaluate the Efficacy and Safety of Livvel Silk oil Soft gel Capsules in patients with Diabetes mellitus, Hypertension and Hyperlipidemia.
SEIDECOSAA Division of M/s INDIAN SILK FIBRE CO, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月5日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- •Polyphagia, Polyurea, Polydipsia, Fatigue, weight loss and Blur vision (if any)
研究概览
简要总结
- The subjects who fulfilled the inclusionand exclusion criteria will be enrolled in the study.
- 100 Participants will berandomized into 2 groups with 50 in each group.
- Arm 1 - Silk oil soft gel capsules + StandardTreatment for Diabetes, Hypertension and Hyperlipidemia: 50 study participants
- Arm 2 - Standard Treatment for Diabetes,Hypertension and Hyperlipidemia: 50 study participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects, aged 18 years and above.
- •Subjects diagnosed with Diabetes with hypertension and hyperlipidaemia, (newly diagnosed and patients who are on treatment).
排除标准
- •1.Subjects presenting with any other life threatening co morbid disease conditions like renal failure, liver failure or severe heart failure.
- •2.Participation in any other clinical study or test panel within the one month prior to entry into the study.
- •3.History of allergy to test product 4.History of HIV, HBV, Malignancy, alcohol or drug abuse.
- •5.Pregnant or lactating subjects.
结局指标
主要结局
•Polyphagia, Polyurea, Polydipsia, Fatigue, weight loss and Blur vision (if any)
时间窗: 4th 8th and 12th week
•Improvement of Systolic and Diastolic blood pressure
时间窗: 4th 8th and 12th week
•Improvement of Inflammatory markers like ESR and CRP.
时间窗: 4th 8th and 12th week
•Fasting blood glucose, Post prandial blood glucose and HbA1c levels
时间窗: 4th 8th and 12th week
•Lowering of LDL/VLDL/TG and increase in HDL
时间窗: 4th 8th and 12th week
•Number of Cardiovascular events (myocardial infarction/ stroke) during the study period.
时间窗: 4th 8th and 12th week
次要结局
- •Patient and investigator feedbacks and Quality of Life will be assessed(•Adverse event monitoring (Laboratory data will be compared Pre and Post study to monitor for the safety of the subjects).)
研究者
研究点 (1)
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