To study the effect of Ayurvedic medicine on abnormal lipid profile

Phase 3

• Conditions: Health Condition 1: E889- Metabolic disorder, unspecified

• Registration Number: CTRI/2022/03/040717
• Lead Sponsor: Desh Bhagat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Having all or at least two of the lipids above the normal range as under :

�Serum cholesterol level- �200 mg/ dl (�5.2 mmol/l)

�Serum Triglycerides level-�150 mg/ dl (�1.7 mmol/l)

ââ?¬Â¢HDL-C level-Ã?â??40 mg/dl (Ã?â??1.04 mmol/l)

�LDL- level - �130 mg/dl (�3.4 mmol/l)

Participant willing and able to participate in the study.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 <br/ ><br>2.Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 <br/ ><br>3.Percent Change From Baseline in Fasting High density lipoprotein (HDL-C) at Week 12 <br/ ><br>4.Percent Change From Baseline in Fasting Serum Triglycerides (TG) at Week 12 <br/ ><br>Timepoint: 84 days

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>ii.Percentage of participants with decrease of Fasting LDL-C of more than 50% from base line at week 12 <br/ ><br>iii.Percentage of participants with decrease of Fasting Serum cholesterol of more than 50% from base line at week 12 <br/ ><br>iv.Percentage of participants with decrease of Fasting Serum triglycerides (TG) of more than 50% from base line at week 12 <br/ ><br>v.Change in body weight and body mass index (BMI) in 12 weeks. <br/ ><br>vi.Percentage of participants with increase of fasting High Density lipoprotein Cholesterol (HDL-C) of more than 50% from base line at week 12 <br/ ><br>Timepoint: 84 days