Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
None listed
Sponsors
Desh Bhagat University
Eligibility
Inclusion criteria
Inclusion criteria: Having all or at least two of the lipids above the normal range as under : ââ?¬Â¢Serum cholesterol level- ââ?°Â¥200 mg/ dl (ââ?°Â¥5.2 mmol/l) ââ?¬Â¢Serum Triglycerides level-ââ?°Â¥150 mg/ dl (ââ?°Â¥1.7 mmol/l) ââ?¬Â¢HDL-C level-Ã?â??40 mg/dl (Ã?â??1.04 mmol/l) ââ?¬Â¢LDL- level - ââ?°Â¥130 mg/dl (ââ?°Â¥3.4 mmol/l) Participant willing and able to participate in the study.
Exclusion criteria
Exclusion criteria: �Patients with poorly controlled Hypertension ( >160/100mmHg) �Pregnant/ lactating females. �Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immune suppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. �Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) �Patients who have a past history of Atrial Fibrillation, or Severe Arrhythmia �Symptomatic patients with clinical evidence of Heart failure. �Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 200mg/dl) �Patients with concurrent serious hepatic disorder (defined as aspartate amino transferase (AST) and / or alanine amino transferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 3 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL) �Patients with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or Other concurrent severe disease �Patients with evidence of malignancy �History of Hypersensitivity to any of the trial drug or its ingredients �History of Hypothyroidism �Patients who have completed participation in any other clinical trial during the past six (06) months �Patients who received any cholesterol lowering medication within last 08 weeks before screening. �Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 2.Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 3.Percent Change From Baseline in Fasting High density lipoprotein (HDL-C) at Week 12 4.Percent Change From Baseline in Fasting Serum Triglycerides (TG) at Week 12 Timepoint: 84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| i.Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less than or equal to 70 Milligram per Deciliter (mg/dL) at week 12. ii.Percentage of participants with decrease of Fasting LDL-C of more than 50% from base line at week 12 iii.Percentage of participants with decrease of Fasting Serum cholesterol of more than 50% from base line at week 12 iv.Percentage of participants with decrease of Fasting Serum triglycerides (TG) of more than 50% from base line at week 12 v.Change in body weight and body mass index (BMI) in 12 weeks. vi.Percentage of participants with increase of fasting High Density lipoprotein Cholesterol (HDL-C) of more than 50% from base line at week 12 Timepoint: 84 days | — |
Countries
India
Contacts
Public ContactDr Sanjiv Kumar
CARI under Central Council for Research in Ayurvedic Sciences, New Delhi
Outcome results
None listed