| CTRI Number |
CTRI/2026/01/102392 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effects and safety of Cardio Miracle™ Powder in Patients with Diabetes and high cholesterol. |
|
Scientific Title of Study
|
An Interventional, Prospective Clinical Study of CARDIO Miracle™ Powder Assessing Nitric Oxide–Mediated Cardiometabolic EfFects, Safety ProfIle, and In-Use Tolerability in Type 2 Diabetes Mellitus Patients with Dyslipidaemia-Elevated LDL. |
| Trial Acronym |
CARDIOFIT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250055-CM_1.0_16Jan26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Prajapati |
| Designation |
Principal Investigator |
| Affiliation |
Ananta Multispeciality Hospital |
| Address |
4th Floor, Centre Point,
Vandemataram Road, Gota Road,
(Near Vrindavan Heights), Gujarat, India.
Ahmedabad - 382481
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub Investigator |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshwari Patel |
| Designation |
DIrector Operations and Strategic Management |
| Affiliation |
NovoBliss Research Pvt Ltd |
| Address |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| CM Family Legacy LLC
2330 Chaco Trail
St. George, Utah 84770 |
|
|
Primary Sponsor
|
| Name |
CM Family Legacy LLC |
| Address |
2330 Chaco Trail
St. George, Utah 84770
|
| Type of Sponsor |
Other [Nutraceuticals] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vipul Prajapati |
Ananta Multispeciality Hospital |
4th Floor, Centre Point,
Vandemataram Road, Gota Road,
(Near Vrindavan Heights), Gujarat, India.
Ahmedabad - 382481
Ahmadabad
GUJARAT |
7948983895
consultant@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, (2) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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,
Route of Administration: Oral
Storage Condition: Room temperature (15°C to 30°C)
Study Duration: 90 Days
|
| Comparator Agent |
NIL |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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/m².
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.
|
|
| ExclusionCriteria |
| Details |
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 m².
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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). |
Day 30(± 4 Days), Day 60(± 4 Days) and Day 90 (± 4 Days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
Day 01, Day 30, Day 60 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2027 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Prospective, Interventional,
single-centre, single-arm, clinical safety and efficacy study on Cardio Miracle™
Powder- a plant based dietary supplement
formulated to promote sustained nitric oxide (NO) release and endothelial
function in patients with Type 2 Diabetes Mellitus with elevated LDL level.
A total of
32 patients including male and non-pregnant/non-lactating females (both in
equal ratio) aged between 18-65 years with type 2
Diabetes Mellitus and elevated LDL levels will be enrolled in the study to
complete evaluation of 30 patients for the study.
A sufficient number of patients will be
pre-screened based on HbA1C (7% to 10% gm) and high LDL levels (130-189 mg/dL)
levels to ensure that enough patients successfully qualify the screening. The
potential patients will be screened on the basis of inclusion and exclusion
criteria only after obtaining written informed consent from the subjects.
Subjects will be contacted telephonically by the recruiting department prior to
the enrolment visit. The subjects will be requested to bring any previous
medications and relevant laboratory reports on the day of the study visit.
The subjects will be instructed to visit
the facility as per the below visits: ü Pre-Screening- Generic Pre-Screening Consent, HbA1c level and LDL level ü Visit 01 (Within 21 Days from Day 01)- Screening, Informed Consent Document Obtained, Safety laboratory parameters. ü Visit 02 (Day 01)- Enrolment, baseline evaluations, Vitals, Biomarkers, test treatment phase ü Visit 03 (Day 30 ± 4 Days)- Adherence Review, Vitals, Evaluation, test treatment phase ü Visit 04 (Day 60 ± 4 Days)- Adherence Review, Vitals, Evaluation, test treatment phase ü Visit 05 (Day 90 ± 4 Days)- Adherence Review, Vitals, biomarker and safety laboratory parameters, End of Study |