Health Condition 1: null- Dyslipidemia
Conditions
Interventions
Dosage form â?? Sachet of 3 gm each Route of Administration â?? Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-Plastic jar of 90 grams containing 30 sachets Du
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients having LDLc 100mg/dL - 160mg/dL and / or Serum cholesterol 200mg/dL - 250mg/dL and / or Serum Triglycerides â??150mg/dL - 250 mg/dL 2. Willing and able to participate in the study for 16 weeks
Exclusion criteria
Exclusion criteria: 1. Patients who have received any cholesterol lowering medication (Modern Drug) within last 8 weeks. 2. Patients having Type III and Type IV hypercholesterolaemia 3. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 4. Patients with evidence of malignancy 5. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immunosuppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. 6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 7. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 8. Symptomatic patient with clinical evidence of Heart failure. 9. Patients having uncontrolled Diabetes Mellitus i.e.HbA1c > 10% 10. Patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 2 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel disease or any other condition that may jeopardize the study.. 11. Pregnant/ lactating females. 12. Patients on oral contraceptives. 13. Alcoholics and/or drug abusers. 14. H/o hypersensitivity to any of the trial drugs or their ingredients. 15. Patients who have completed participation in any other clinical trial during the past six (06) months. 16. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Lipid ProfileTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Quality of Life (SF-36 Health Survey) ScoreTimepoint: At Baseline, 84th day and at the end of follow up after 14th week | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed