Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: CitraFit TM: Nutraceutical capsules, twice a day for 90 days
Control Intervention1: Statins: Standard of care for 90 days
Sponsors
Ziran India
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who voluntarily participate in this study by signing their Informed Consent Form (ICF) in the local language prior to any study-mandated procedure Males or females aged 35 to 65 years at the time of signing the ICF Subjects diagnosed with increased Cardiovascular Risk Factors, evidenced by laboratory investigations conducted within 6 months prior to the screening visit and confirmed again during the screening visit. The criteria include Total Cholesterol more than 1.5 times ULN Triglycerides more than 1.5 times ULN High-Density Lipoprotein more than 40 mg per dL Low-Density Lipoprotein more than 130 mg per dL Subjects who are on statins should be on a stable dose at least for 3 months prior to the screening visit for Arm 1 and Arm 2 Subjects who are newly diagnosed (treatment-naive) are taken for Arm 3. Type 2 diabetes subjects stable on treatment for last 2 months. Subjects ready to discontinue the use of supplementations including vitamins glucosamine chondroitin herbals or any other ongoing nutritional supplements Willing to comply with all the study-related activities
Exclusion criteria
Exclusion criteria: Currently participating in another investigational study Female subjects who are pregnant or lactating. History of severe allergies to Citrus Bioflavonoids or similar supplements. Concomitant use of medications known to interact with herbal remedies. Severe psychiatric disorders. Subjects with a planned or anticipated surgery during the study period. Subject history of any respiratory or breathing disorders. Subjects with HIV Positive status. Alcohol intake more than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers. Clinically significant or abnormal laboratory results other than those relevant to the study indication during screening. Diagnosis of Type 1 diabetes, recent surgery, liver diseases, jaundice, kidney issues, use of antidepressants, sleep disorders, psoriasis, and inflammatory diseases like rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, asthma, chronic obstructive pulmonary disease (COPD) and any other inflammatory diseases which in the opinion of the Principal Investigator (PI) may impact the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Serum TG levels from baseline to end of treatment Change in TC levels from baseline to end of treatment Change in LDL Levels from baseline to end of treatment Change in HDL levels from baseline to end of treatment Change in Serum NO levels from baseline to end of treatment Change in SBP from baseline to end of treatmentTimepoint: Day 0 and 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Monitoring adverse events (and overall tolerability of CitraFit Improvements in Risk Factor Control Stability of lipid profiles blood pressure and cardiovascular health Exercise tolerance improvement as measured by TMT parameters exercise duration METs achieved ST segment changes heart rate recovery Changes in oxygen saturation using pulse oximeter monitoringTimepoint: Day 0 and 90 | — |
Countries
India
Contacts
Public ContactDr Vikrant Tripathi
Ziran India
Outcome results
None listed