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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female individuals with the age between 18 to 65 years at the time of consent.
- •Subject diagnosed with T2DM.
- •Subjects with currently having HbA1c values between 7% to 10 %.
- •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.
- •Subjects with a body mass index (BMI) between 18.5 and 35.0 kg/m².
- •Subjects are willing to give written informed consent and are willing to come for regular follow up.
- •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.
- •Subjects who have not participated in any other similar clinical study in last 3 months.
- •Subject is willing to provide a copy of the medical record or prescription record.
- •Willing to use test treatment throughout the study period.
排除标准
- •Subjects having known hypersensitivity or allergy to active ingredients.
- •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.
- •Subjects with elevated serum creatinine levels and an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m².
- •Subjects with elevated hepatic transaminases, defined as serum SGPT (ALT) greater than 100 U/L and/or SGOT (AST) greater than 118 U/L.
- •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.
- •Subjects who are hypersensitive to any of the components of the treatment.
- •Subjects who have planned major changes in the lifestyle (i.e., diet, exercise level, significant travel) during the duration of the study.
- •Participation in a study of any other treatment within 90 days prior to the screening.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
研究者
Dr Vipul Prajapati
Ananta Multispeciality Hospital