CTRI/2020/01/022814进行中（未招募）未知
A Multicentre, Single arm, Open label, Clinical trial to determine the Efficacy and Safety of Ischemia Reversal Program (IRP) along with diet modification as an add-on therapy to conventional treatment on plaque volume of Coronary Artery Disease (CAD) subjects.
Vaidya Sane Ayurvedic Lab Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects between 40 to 75 years of age.
- •2.Subjects with diagnosis of significant Coronary Artery Disease (CAD) with Non significant atherosclerotic plaque ââ?°Â¥ 30% toââ?°Â¤70% in target vessel which should be of minimum of 40 mm as detected by Intravascular Ultrasound(IVUS) guided angiography.
- •3.Subjects with known case of Type 2 Diabetes Mellitus (on regular and stable medication from last 3 months).
- •4.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •1.Subject with severe Calcified plaque or no plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
- •2.Subjects with total atheroma volume of ââ?°Â¤ 50mm3 as detected by Intravascular Ultrasound (IVUS) guided angiography at screening visit.
- •3.Subjects with history of Coronary Artery Bypass Grafting (CABG) and Percutaneous transluminal coronary angioplasty (PTCA).
- •4.Subjects with known case of symptomatic CAD (Chest pain at Rest).
- •5.Subjects with recent acute coronary syndrome (within last 3 months).
- •6.Subjects with acute heart failure (within 24hrs).
- •7.Subjects with all anomalies of coronary arteries.
- •8.Subjects with uncontrolled hypertension with blood pressure ââ?°Â¥ 180/100 mm Hg.
- •9.Subjects with BMI < 23 kg/m2.
- •10.Subjects with Type 1 Diabetes Mellitus.
- •11.Subjects with known case of Diabetic ketoacidosis.
- •12.Subjects with known case of Active malignancy
- •13.Subjects with known case of Hyperthyroidism.
- •14.Subjects with serum creatinine level ââ?°Â¥ 2 mg/dL.
- •15.Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
- •16.Subjects with physical disability in any form leading to immobilization.
- •17.Subjects with Irritable bowel syndrome.
- •18.Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles).
- •19.Subjects with Hemorrhoids (2nd or 3rd degree).
- •20.Subjects with suspected inability or unwillingness to comply with the study procedures.
- •21.Subjects with known case of Soya food allergy
- •22.Subjects with suspected hypersensitivity to any of the ingredients of study medication.
- •23.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •24.Suspected inability or unwillingness to comply with the study procedures.
- •25.Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
研究者
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