A clinical study to see the effect of some Ayurvedic formulation in the management of Lipid Disorders.

Phase 2

• Conditions: Health Condition 1: null- Dyslipidemia

• Registration Number: CTRI/2012/03/002528
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified