A Prospective, Open Label, Randomized Controlled Study to Evaluate the Benefits of Saffola Oats with Diet & Exercise in Improving Cardiovascular Health of Hyperlipidemic Individuals - Nil

Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1 Male & female, Age - 25 to 50 yrs
•2 LDL Cholesterol in between 130 - 190 mg %
•3 BMI 23 - 30 kg/m2
•4 Patient is clinically stable and all laboratory investigations are clinically acceptable as per P.I Discretion

•1. BMI > 30 kg/m2
•2. Patients suffering from any 1 of the following diseases that can be considered
•as a risk factor‐ Diabetes, CAD, CVD, Coronary Artherosclerosis and uncontrolled hypertension.
•3. Patient undergone coronary artery bypass graft (CABG) or any other major cardiac surgery.
•4. Patients taking lipid lowering drugs including Simvastatin, Pravastatin,Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin etc.
•5. Patients with blood pressure > 140/90 mmHg
•6. Patients with clinical signs and symptoms of liver, kidney or thyroid disorders.
•7. Patients having TB
•8. Pregnant and lactating women
•9. Oat users
•10. Patients having known hypersensitivity to Oats or Oats products.
•11. Patients who has a fiber intake > 25 g/day
•12. Patients who are on caloric reduction diet/ change dietary constituents frequently
•13. Athletes or Patients who do any form of exercise everyday (jogging, brisk walking, swimming, weight lifting etc.)
•14. Patients smoking more than 10 cigarettes/ day
•15. Patients consuming more than 20g alcohol/ day
•16. Patients who are unlikely to comply with Protocol requirements e.g. uncooperative attitude, patients who are frequent travellers, inability to return for the visits
•17. Patient participating in any other clinical trial.

发起方

Spectrum Clinical Research Pvt Ltd