Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of atherogenic dyslipidemia Participants at intermediate or high risk of ASCVD disease or risk as assessed through ASCVD calculator. Participants on stable doses of statins for the preceding 6 weeks. Body Mass Index (BMI) more than or equal to 18.5 and less than 35. Written informed consent prior to screening Willingness to adhere to the treatment for a period of 24 weeks (Newly diagnosed dyslipidemia cases fulfilling the inclusion criteria will be included after inducting them on a statin therapy for atleast 6 weeks to stabilize the cholesterol levels as a run in phase before inducting into the trial and adding Arjuna/placebo)
Exclusion criteria
Exclusion criteria: Poorly controlled diabetes mellitus or diabetes mellitus requiring insulin therapy Hypertension (reproducible, repeated 5 minutes apart) sitting BP more than 160 systolic or more than 100 mmHg diastolic) Participants who are contraindicated to statin therapy such as deranged liver function, history of muscle-related side effects when taking a statin or fibrate, a family history of myopathy or rhabdomyolysis. Co-morbid conditions that would interfere with study activities or response to treatment, which may include: Severe chronic pulmonary disease, thyroid disorders, endocrine diseases, local, systemic acute or chronic infectious illness, cardiac arrhythmias, neurological, psychological illness. Pregnancy and lactation Active substance abuse like alcohol or drug abuse in any form or history of alcohol/drug abuse or dependence within 6 months prior to study enrolment. History or evidence of any other condition or disease that, in the opinion of the investigator would interfere with the study evaluation, procedures, or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting serum LDL cholesterol Timepoint: Baseline, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage Change in Apo B The proportion of participants in the normal reference range for fasting T. cholesterol Change in fasting HDL-cholesterol Changes in the apolipoprotein A1 and AII proteoforms Change in Cholesterol Efflux capacity Change in pro B-type natriuretic peptide (NTpro BNP Change in hs CRP, IL 6, TNF alpha Change in Resting blood pressure Improvement in fasting insulin Improvement in homeostatic model assessment to quantify insulin resistance Improvement in Body Fat composition by DEXA Time Frame Relationship between baseline Coronary Artery Calcium Score and the changes in the above-listed biomarker changes Timepoint: Baseline, 12 and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Vidyashree Anchan
Central Ayurveda Research Institute, Bengaluru
Outcome results
None listed