Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with Direct LDL-C more than 130 at the time of screening Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1)Subjects not willing for trial 2)Subjects with Diabetes Mellitus Type I and Type 2 Diabetes Mellitus 3)Subjects with uncontrolled Hy pothyroidism or Hyperthyroidism 4)Known cases of Severe/Chronic hepatic or renal disease 5)Known subject of any active malignancy 6)Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization 7)Subjects with uncontrolled or Malignant Hypertension 8)Subjects ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia 9)Subjects X- ray chest showing any active lesion of tuberculosis 10)Subjects having known HIV infection 11)Subjects using any other investigational drug within 1 month prior to recruitment 12)Pregnant and Lactating females 13)Subjects currently participating in any other Clinical study 14)Any other medical or surgical condition considered unsuitable for patient participation in the study as per Investigatorââ?¬•s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Effect on the change in direct LDL-C level at the end of study (08 weeks) 2)Effect on the change in Triglycerides levels at the end of study (08 weeks) Timepoint: at the end of 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Total Cholesterol Triglycerides LDL and HDL at the end of 4 and 8 weeks 2.Change in Body Weight BMI Waist circumference and Waist to hip ratio at the end of 4 & 8 weeks 3.Overall efficacy of the study and control product as per the physician at the end of 8 weeks 4.Safety assessment by assessing adverse drug reactions abnormal laboratories values at the end of 4 and 8 weeks 5.Overall safety assessment of the intervention as per the physician at the end of 8weeks Timepoint: at the end of 4 and 8 weeks | — |
Countries
India
Contacts
Shri Gurudeo Ayurved College Gurukunj Ashram