Health Condition 1: E669- Obesity, unspecified Health Condition 2: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Name-Biozen herbal syrup
Dose- 10ml orally OD at morning after food with 1 glass of water.
Duration - 3 Months.
Route of Administration -Oral
Formulation - Syrup
Frequency - 1-0-0 ( mo
Sponsors
Aathithya herbals
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the Efficacy of Biozen syrup in preventing Hyperlipidaemia. 2. Rapid recovery from symptoms. 3. The change in score (baseline to Visit 4) for domain score of the Hyperlipidemia-related Quality of Life (ORQOL)Timepoint: 1.To access is there any improvements in general fatigue at 4 th week. 2. To access is there any improvements in body energy levels at 4th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To find out, incidence of adverse events during the study period. 2.To evaluate treatment Adherence/Compliance.Timepoint: 1.To findout is there a decrease in Apolipoprotien A1 & Apolipoprotien B in blood at 12th week. 2. To check is there is decrease in CRP levels in blood at 12th week. | — |
Countries
India
Contacts
Public ContactDrMGRajanandh
SRMIST SRM College of Pharmacy
Outcome results
None listed