Assessing the safety and efficacy of biozen syrup for managing hyperlipidemia: An open-label study.

Not Applicable

Conditions: Health Condition 1: E669- Obesity, unspecifiedHealth Condition 2: E669- Obesity, unspecified

Recruitment & Eligibility

Inclusion Criteria

1. Male or female with age of 20-60 years.

2. BMI between 25 to 40 kg/m2.

3. Subjects with elevated lipid profile parameters.

(i) Total Cholesterol more than 200mg/dl (or)

(ii) Triglycerides more than 150mg/dl (or)

(iii) LDL more than 130mg/dl

4. Willing to give written informed consent.

Exclusion Criteria

1. Subjects with abnormal hematologic function (Hemoglobin 8gm/dl, WBC count

3000/mm3, platelet count 100,000/mm3).

2. Any concomitant serious disorders of the liver ,kidneys , heart, lungs and other organs

3. Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or

intellectual problems likely to limit the validity of consent to participate in the study or

limit the ability to comply with protocol requirements.

4. Abnormally elevated liver enzymes (ALT and/or AST more than 2 times ULN).

5. Elevated creatinine phosphokinase (CPK) (more than 3 times ULN).

6. Gravid women and lactating mother.

7. Heavy smoker, Chronic alcoholic, or drug abuse subjects

8. Known cases of malignancy, HIV infection, AIDS, etc.

9. Subject who participated in any other clinical investigation using an experimental drug in

the past 3 months.

10. Participants are not willing to sign the ICF and to attend treatment schedule regularly.

Primary Outcome Measures

Name	Time	Method
1.To assess the Efficacy of Biozen syrup in preventing Hyperlipidaemia. <br/ ><br>2. Rapid recovery from symptoms. <br/ ><br>3. The change in score (baseline to Visit 4) for domain score of the Hyperlipidemia-related <br/ ><br>Quality of Life (ORQOL)Timepoint: 1.To access is there any improvements in general fatigue at 4 th week. <br/ ><br>2. To access is there any improvements in body energy levels at 4th week.

Secondary Outcome Measures

Name	Time	Method
1.To find out, incidence of adverse events during the study period. <br/ ><br>2.To evaluate treatment Adherence/Compliance.Timepoint: 1.To findout is there a decrease in Apolipoprotien A1 & Apolipoprotien B in blood at 12th week. <br/ ><br>2. To check is there is decrease in CRP levels in blood at 12th week.