Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Phytolite Plant sterol 95%: 5g once a day for 60 days. Mix it well in warm/Room Temperature milk and consume.
Control Intervention1: Placebo: 5g once a day for 60 days. Mix it well in w
Sponsors
Matrix fine Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male & Female subjects aged between 30 to 60 Dyslipidemia with any of the two parameters- 1. Subjects with- Total Cholesterol � 240 mg/dL, 2. Triglycerides � 200 mg/dL 3. Subjects with high LDL in the range of 130-220 mg/dL both inclusive Subjects with or without comorbidities but stable on a prescription Subjects with or without statin treatment
Exclusion criteria
Exclusion criteria: Subjects with any acute illness requiring immediate medical care. Subjects who are contraindicated for statins/ phytosterols. Known subject with CRF and at critical stage at screening. Known subjects of hepatic failure/inflammation. Patients with uncontrolled diabetes and hypertension. Body mass index (BMI) >40 kg/m2. Subject proving to be unfit from investigators discretion. Pregnant and lactating women. Patients who participated in any clinical trial within 30 days before enrollment into the study. Subejcts in active infection phase for Covid 19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in lipid profile: total cholesterol, triglycerides, LDL, VLDL, HDL 2.Changes in Body Weight 3.Changes in BMI, Hip waist ratio 4.Changes in symptoms related to hypercholesterolemia Timepoint: Screening, baseline, day 30, day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction in dose of statin 2.Achievement of target levels of total cholesterol, serum triglycerides and LDL cholesterol, HDL 3.Patient compliance 4.Change in Quality of life of subjects Timepoint: Screening, baseline, day 30, day 60 | — |
Countries
India
Contacts
Public ContactReema Shah
Matrix Fine Science Pvt Ltd
Outcome results
None listed