Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Group A (AMUAG-A-1): Two capsules as a single dose, 30 minutes before morning meal, with a glass of water for 90 days.
Intervention2: Group B (AMUAG-P-2): Two capsules as a single dose
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: Fasting total cholesterol concentration: greater than or equal to 200 mg per dL Fasting triglyceride concentration: 150 to 499 mg per dL Fasting LDL-cholesterol concentration: greater than or equal to 145 - less than or equal to 189 mg per dL, with a mean greater than or equal to 160 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 to 30 kg per m2 at screening; 6. Participants providing voluntary, written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study. 1. Known or suspected allergy or hypersensitivity to any component of the investigational product; 2. Participants with known iron deficiency or iron deficiency anemia, or those requiring iron supplementation, will be excluded; 3. Any other cardio-diabetic comorbidity as per investigators discretion; 4. Difficulty sleeping due to a medical condition; 5. History of a neurological disorder; 6. History of bipolar disorder, psychotic disorder, posttraumatic stress disorder, or current psychiatric disorder that requires medication; 7. On-going 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); 8. History of substance abuse or dependence; 9. History or current evidence of a clinically significant cardiovascular disorder at pre study visit; 10. Taking certain prohibited medications; 11. Consumption of more than 15 cigarettes a day; 12. History of malignancy less than or equal to 5 years prior to signing an informed consent; 13. Participants on medication that may interfere lipid metabolism; 14. Participants consuming nutraceuticals and health supplements for past three months; 15. Pregnant women and nursing mothers or females planning to conceive during the study; 16. Females of childbearing potential unwilling to employ appropriate and reliable methods of contraception during the study till 07 days after the completion of the study. 17. 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 |
|---|---|
| Assessment of changes in fasting lipid parameters including total cholesterol (TC), low-density lipoprotein cholesterol (LDL), triglycerides (TG), high-density lipoprotein cholesterol (HDL), and remnant cholesterol (RC)Timepoint: at screening, day 30, day 60 and day 90 | — |
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, day 60 and day 90;2. Assessment of change in Body weight, BMI, waist and hip circumference Timepoint: at baseline, day 30, day 60 and day 90;3. Assessment of changes in metabolic state (MetS-Z score)Timepoint: at baseline, day 30, day 60 and day 90;Safety Endpoint 1. Changes in biochemical parameters such as liver function test (LFT) and renal function test (RFT) Timepoint: at baseline and day 90;2. Incidence and severity of adverse eventsTimepoint: from baseline to end of the study (day 90);3. Changes in compliance and tolerabilityTimepoint: at day 30, day 60 and day 90 | — |
Countries
India
Contacts
Public ContactDr Dhananjay Zutshi
Gunjkar Muitispeciality Hospital
Outcome results
None listed