CTRI/2018/09/015633进行中（未招募）未知
A Randomized, Open label, Comparative 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 versus conventional treatment alone on plaque volume of Coronary Artery Disease (CAD) patients.
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 known case of significant Coronary Artery Disease (CAD) with soft plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
- •3. Subjects with known case of CAD with stable dose of standard therapy for at least 3 months.
- •4.Subjects with BMI in the range of 26 to 30 kg/m2.
- •5.Subjects with known case of Type 2 Diabetes Mellitus with HbA1c value between 7% to 8% (on regular and stable medication from last 3 months).
- •6.Subjects with known case of controlled Hypertension with blood pressure up to 130/90 (on regular and stable medication since last 3 months).
- •7. 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 history of Coronary artery bypass grafting (CABG).
- •3. Subjects with known case of symptomatic CAD (Chest pain at Rest).
- •4. Subjects with recent acute coronary syndrome (within last 3 months).
- •5. Subjects with acute heart failure (within 24 hrs).
- •6. Subjects with Irritable bowel syndrome.
- •7. Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles).
- •8. Subjects with Hemorrhoids (2nd or 3rd degree).
- •9. Subject with known case of Asthma or COPD.
- •10. Subjects with known case of Cancer.
- •11. Subjects with physical disability in any form leading to immobilization.
- •12. Subjects with Anemia (Hemoglobin less than 10 gm/dL).
- •13. Subjects with known case of Thyroid dysfunction.
- •14. Subjects with hepatic or renal insufficiency.
- •15. Subjects with suspected inability or unwillingness to comply with the study procedures.
- •16. Subjects with suspected hypersensitivity to any of the ingredients of study medication.
- •17. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •18. Suspected inability or unwillingness to comply with the study procedures.
- •19. 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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