Health Condition 1: E11- Type 2 diabetes mellitus Health Condition 2: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: CARDIO Miracle Powder: Mode of Administration: Add one serving of Cardio Miracle powder in 240 mL of water and mix thoroughly until complete dissolution.
Frequency: Twice daily,
Rout
Sponsors
CM Family Legacy LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and female individuals with the age between 18 to 65 years at the time of consent. 2)Subject diagnosed with T2DM. 3)Subjects with currently having HbA1c values between 7% to 10 %. 4)Subjects with currently having borderline and high LDL values between 130 to 189 mg/dL 5)Subjects having prescription of diabetes and cholesterol related laboratory reports at the time of screening. 6)Subjects with a body mass index (BMI) between 18.5 and 35.0 kg/m . 7)Subjects are willing to give written informed consent and are willing to come for regular follow up. 8)All concomitant medications must have been maintained at a stable dose and regimen for a minimum of 4 weeks prior to screening, with no anticipated changes during the study period. 9)Subjects who have not participated in any other similar clinical study in last 3 months. 10)Subject is willing to provide a copy of the medical record or prescription record. 11)Willing to use test treatment throughout the study period.
Exclusion criteria
Exclusion criteria: 1)Subjects having known hypersensitivity or allergy to active ingredients. 2)Subjects diagnosed with other types of Diabetes like T1DM or specific type of DM (i.e., pancreatic injury induced DM, diabetes mellitus caused by Cushing s syndrome or acromegaly, Latent Autoimmune Diabetes in Adults (LADA), Maturing Onset diabetes of the young (MODY) etc.) 3)Subjects receiving thiazolidinediones or intensive insulin regimens, or those who have initiated or had a dose change of GLP-1 receptor agonists (e.g., exenatide, liraglutide, semaglutide, dulaglutide, tirzepatide) or SGLT-2 inhibitors (e.g., dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, remogliflozin) within 12 weeks prior to screening will be excluded. Participants receiving these agents must be on a stable dose for at least 12 weeks prior to screening and throughout the study, as recent initiation or dose modification may independently affect lipid metabolism, inflammatory markers, renal function, and cardiovascular outcomes, thereby potentially confounding the assessment of the nitric-oxide mediated effects. 4)Subjects with elevated serum creatinine levels and an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m . 5)Subjects with elevated hepatic transaminases, defined as serum SGPT (ALT) greater than 100 U/L and/or SGOT (AST) greater than 118 U/L. 6)Subjects currently receiving nitrate therapy (e.g., nitro-glycerine, isosorbide dinitrate, isosorbide mononitrate, sodium nitroprusside, or amyl nitrite) or antiplatelet agents/blood thinners (e.g., aspirin, clopidogrel, prasugrel, ticagrelor, or ticlopidine) or anti-coagulants (e.g. Warfarin) 7)Subjects who have deviations in the laboratory reports which could warrant exclusion from the study, as per investigator s opinion. 8)Subjects who are hypersensitive to any of the components of the treatment. 9)Subjects who have planned major changes in the lifestyle (i.e., diet, exercise level, significant travel) during the duration of the study. 10)Participation in a study of any other treatment within 90 days prior to the screening. 11)Pregnant or breastfeeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the in-use tolerability of the test treatment by assessing any adverse events gastrointestinal disturbances (nausea, bloating, diarrhoea), headache, heart palpitation evaluated by the physician or a physician-trained evaluator when the test treatment is administered twice daily from baseline at Day 01 (pre-treatment) to post-dose of the test treatment on Day 30 ( 4 days), Day 60 ( 4 days), and Day 90 ( 4 days).Timepoint: Day 30( 4 Days), Day 60( 4 Days) and Day 90 ( 4 Days). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of the test treatment by assessing change in Inflammatory biomarkers- hs-CRP, ESR from baseline to post-dose of the test treatment.Timepoint: Day 01 and Day 90;2.To evaluate the efficacy of the test treatment by assessing change in Glycaemic Control Biomarker through HbA1C levels from baseline at post-dose of the test treatment.Timepoint: Day 01 and Day 90;3. To evaluate the efficacy of the test treatment by assessing change in Nutritional Biomarker through 25-OH Vitamin D levels from baseline at post-dose of the test treatment.Timepoint: Day 01 and Day 90;4. To evaluate the efficacy of the test treatment by assessing change in Renal Function Biomarkers through BMP (Blood Sugar Level, Serum Calcium, Serum Na+, Serum K+, Serum Cl-, Bicarbonate (HCO3-), Blood Urea Nitrogen, Creatinine), eGFR levels from baseline at post-dose of the test treatment.Timepoint: Day 01 and Day 90;5. To evaluate the efficacy of the test treatment by assessing change in change in Lipid Metabolism through LDL, HDL, Total Cholesterol, Triglycerides, VLDL, Lipoprotein(a) and ApoB levels from baseline at post-dose of the test treatment.Timepoint: Day 01 and Day 90;6. To evaluate the efficacy of the test treatment by assessing change in change in Vital Signs such as Blood Pressure and Pulse Rate through BP apparatus by physician or physician trained evaluator from baseline at post-dose of the test treatment.Timepoint: Day 01, Day 30, Day 60 and Day 90;7. To evaluate the efficacy of test treatment by assessing change in anthropometric parameters- body weight, BMI, hip and waist ratio using calibrated measuring tape and weighing machine from baseline at post dose of the test treatment.Timepoint: Day 01, Day 30, Day 60 and Day 90;8. To evaluate the efficacy of the test treatment by assessing change in change in Subjective Evaluation through WHOQOL-BREF from baseline at post-dose of the test treatment.Timepoint: Day 01, Day 30, Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactMaheshwari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed