Health Condition 1: I259- Chronic ischemic heart disease, unspecified
Conditions
Interventions
Intervention1: Reverse Diet Kit: Test Product: Reverse Diet Kit
Dose: pre portion products for every meal as per the diet chart mentioned in Appendix 2 for 12 weeks (84 days) along with standard of ca
Sponsors
Vaidya Sane Ayurved Labs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Literate adult Male or Female, aged between 18 to 65 years (both inclusive) who agrees to follow a vegetarian diet during the study duration and carry smart phone and are comfortable with using application to capture data on daily basis like capturing and uploading photo of meals for compliance purpose. 2.Subjects with BMI between 23 to 35 Kg/m2(both inclusive). 3.Subjects with self-reported history of stable Coronary Artery Disease (CAD) and total atheroma volume between 300 mm3 to 1500 mm3 as determined in CT coronary angiography. A previously available CT coronary angiography conducted within 15 days of screening can also be considered. 4.Patients who voluntarily agrees to sign the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study and agrees to comply to the study requirements strictly like adhering to meal plan. 5.Those who can comply with the requirements and process in the clinical study. 6.Females of childbearing potential with negative urine pregnancy test at the time or screening who agrees to voluntarily adopt effective contraceptive measures during the study and do not have a plan to conceive.
Exclusion criteria
Exclusion criteria: 1.Acute cases of CAD. 2.Subjects with BMI less than 23Kg/m2. 3.Subjects with calcified plaque having a Calcium score more than 1000 as assessed in CT Coronary Angiography. A previously available CT coronary angiography conducted within 15 days of screening can also be considered. 4.Subjects with Left Ventricular Ejection Fraction less than 40% in 2D Echogram. A previously available 2 D echogram conducted within 2 months of screening can also be considered. 5.Subjects infected with COVID-19 within last 2 months or known CO-RAD score of 4 or higher within last 2 weeks in Chest CT, if available. 6.Subjects not willing to follow study requirements or have difficulty in compliance. 7.Subjects with self-reported history of Coronary Artery Bypass Grafting (CABG). 8.Subjects with self-reported history of unstable respiratory disease. 9.Subjects with Creatinine more than 1.5 mg/dL 10.Subjects with self-reported history of Hyperthyroidism. 11.Subjects with self-reported history of sinus tachycardia 12.Subjects with Hypertension nonresponsive to therapy 13.Triglycerides and Total Cholesterol is more than 5 times of upper normal limit or Low Density Lipoprotein is more than 3 times of upper normal limit in lipid profile test. 14.Subjects naÃ?¯ve to statin or recently added a statin within 12 weeks in the treatment. 15.Subjects with self-reported history of more than 1 stent 16.Self-reported history of renal, hepatic, gastrointestinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigatorââ?¬•s judgment. 17.Chronic smokers consuming more than 5 cigarettes per day. 18.Unfit for voluntarily providing consent. 19.Patients on immunosuppressive therapy. 20.Patients who participated in another clinical trial within 1 month before screening. 21.Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study. 22.Lactating or pregnant females. 23.Recent weight loss by 5% (in last 12 week) prior to screening 24.Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months 25.Participants taking drugs or diet foods that affect their weight within 3 months prior to screening 26.Patients with planned procedures / Surgeries in next 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction in total atheroma volume using CT coronary angiography. 2.Change in Total cholesterol, High density lipoprotein and low-density lipoprotein 3.Reduction in Body weight, abdominal girth and BMI Timepoint: 1.Reduction in total atheroma volume from baseline to end of treatment using CT coronary angiography. 2.Change in Total cholesterol, High density lipoprotein and low-density lipoprotein at baseline, Day 28 Ã?± 1 Day, Day 56 Ã?± 1 Day and end of treatment. 3.Reduction in Body weight, abdominal girth and BMI at screening, baseline, Day 28 Ã?± 1 Day, Day 56 Ã?± 1 and end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of Adverse Events or Serious Adverse Events. 2. Change in Kidney function test (Creatinine, BUN, Uric acid, Total Protein, Albumin), Liver function test (AST, ALT, GGT, ALP, Albumin, Total Protein, Total Bilirubin), Complete blood count (RBC, TLC, DLC, hemoglobin, hematocrit, and platelets) and Urinalysis (pH, Protein, Glucose, RBC, Ketones, Bilirubin and Specific gravity)Timepoint: baseline to end of treatment | — |
Countries
India
Contacts
Public ContactSubham Dutta
Vaidya Sane Ayurved Labs Private Limited
Outcome results
None listed