Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Group 1: Test product LSCM01 capsule.: One LSCM01 capsule twice daily before food for 60 days.
Intervention2: Group 3: Test product LSCM01 capsule + Statin.: One LSCM01 capsule twice da
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and females aged 30 to 60 years both inclusive; 2.Clinically diagnosed with dyslipidemia, must exhibit specific fasting lipid profiles, meeting the following thresholds: 1.Fasting total cholesterol concentration 200 to 300 mg per dL 2.Fasting triglyceride concentration 150 to 250 mg per dL 3.Fasting LDL cholesterol concentration greater than 100 mg per dL 4.Fasting VLDL cholesterol concentration greater than 30 mg per dL 3.Participants with or without concomitant statin therapy; 4.Willing and able to follow dietary and lifestyle recommendations; 5.Participants with BMI 26 to 30 kg/m2 at screening; 6.Participants providing voluntary, written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation, 2.Presence of any significant comorbid condition like hypertension, diabetes, 3.Unstable angina, myocardial infarction or stroke within 3 months, 4.Body mass index (BMI) greater than 30 kg per meter square, 5.Severe liver disease (Child Pugh Class C) or ALT AST more than 3 times upper limit of normal (ULN), 6.Severe renal impairment (GFR less than 30 ml per min), 7.History of cancer within 5 years (except non melanoma skin cancer), 8.K C O uncontrolled hypothyroidism (TSH greater than 1.5 times ULN), 9.Demyelinating disorders, 10.Use of fibrates, niacin, fish oils or other lipid altering drugs, 11.Known hypersensitivity to study drug components, 12.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of changes in fasting lipid parameters (total cholesterol, LDL, VLDL, triglycerides, HDL). 2.Assessment of changes in biomarkers like hs-CRP, Apolipoprotein A, B, and creatine kinase.Timepoint: From Screening to end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence and severity of adverse events. 2.Changes in anthropometric parameters like body weight, BMI, waist circumference. 3. Changes in glycemic profile fasting blood glucose, fasting insulin, HbA1c and HOMA-IR tests. 4. Assessment of systolic and diastolic blood pressure changes. 5. Changes in hematological and biochemical parameters. 6. Assessment of tolerability compliance.Timepoint: From Screening to end of the study. | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed