Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Group A (AMUA-H): 2 capsules (AMUA-H) in a single dose once daily orally during the morning meal for 60 days.
Intervention2: Group B (AMUA-L): 2 capsules (AMUA-L) in a single dose once
Sponsors
Tilman SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females aged 30-60 years (both inclusive); 2. Clinically diagnosed with dyslipidemia in past 3 months, must exhibit specific fasting lipid profiles, meeting the following thresholds: 1.Fasting total cholesterol concentration greater than or equal to 200 mg/dL 2.Fasting triglyceride concentration - 150 to 499 mg/dL 3.Fasting LDL-cholesterol concentration - greater than or equal to 130 to less than or equal to 189 mg/dL 3. Participants without concomitant statin therapy (treatment na ve) 4. Willing and able to follow dietary and lifestyle recommendations 5. Participants with BMI 18.5-30 kg/m2at screening 6. Participants providing voluntary, written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy/hypersensitivity to any component of the investigational product. 2. Any other cardio-diabetic comorbidity as per investigators discretion. 3. Difficulty sleeping due to a medical condition. 4. History of a neurological disorder. 5. History of bipolar disorder, psychotic disorder, posttraumatic stress disorder, or current psychiatric disorder that requires medication. 6. Ongoing clinical depression and anxiety disorder (showing moderate to severe diagnosis on Participants Health Questionnaire-9 (PHQ 9) and Generalized Anxiety Disorder-7 (GAD 7) scales). 7. History of substance abuse or dependence. 8. History or current evidence of a clinically significant cardiovascular disorder at pre study visit. 9. Taking certain prohibited medications. 10. Consumption of more than 15 cigarettes a day. 11. History of malignancy less than or equal to 5 years prior to signing an informed consent. 12. Participants on medication that may interfere lipid metabolism. 13. Participants consuming nutraceuticals and health supplements for past three months. 14. Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in fasting lipid parameters including total cholesterol (TC), low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL-C), triglycerides (TG), high-density lipoprotein cholesterol (HDL), and remnant cholesterol (RC)Timepoint: baseline, day 30, and day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of changes in subjective symptom scores (fatigue, joint pain, muscle pain, sweating, lethargy, weakness, exertional dyspnea) using a visual analog scale (VAS) scale.Timepoint: at baseline, day 30, and day 60.;2. Assessment of change in Body weight, BMI, waist and hip circumference.Timepoint: at baseline, day 30, and day 60.;3. Assessment of changes in metabolic state (MetS-Z score)Timepoint: at baseline, day 30, and day 60.;Exploratory endpoint Change in oxidized LDL (ox-LDL) levels in selected treatment groupsTimepoint: at baseline and day 60 | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed