Impact of statin treatment on the Coenzyme Q10 dependent functions in the body
- Conditions
- Health Condition 1: null- Dyslipidemia
- Registration Number
- CTRI/2017/05/008494
- Lead Sponsor
- Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
INCLUSION CRITERIA FOR STATIN GROUP:
1.Patients on statin therapy with any dose and duration.
2.Age >= 18 years
INCLUSION CRITERIA FOR NORMAL HEALTHY VOLUNTEERS:
1.Age >= 18 years
2.Willing to give informed consent
EXCLUSION CRITERIA FOR STATIN GROUP:
1.Patients with diagnosed myopathy before the start of statin therapy or other cause of myopathy
2.Patients with co-existing diabetes or other diagnosed causes of peripheral neuropathy (diabetes, renal insufficiency, use of alcohol, hypothyroidism, cancer, AIDS, connective tissue disorder, heavy metal intoxication, cobalamine and folate deficiency).
3.Patients with reported hearing loss (conductive or sensorineural) before the start of statin therapy
4.Patients who have contraindications for NCT (Pacemakers).
5.Patients taking the following drugs: chemotherapy, gold, phenytoin, amiodarone, isoniazid, ethambutol, metronidazole, nitrofurantoin, chloramphenicol, griseofulvin, disulfiram, dapsone, cimetidine, colchicine, hydralazine, pyridoxine, thalidomide.
EXCLUSION CRITERIA FOR NORMAL HEALTHY VOLUNTEERS:
1.Diabetes
2.Muscular Dystrophies
3.Parkinsonâ??s Disease
4.Patients taking statins, antidiabetic drugs, anti-depressants, chemotherapeutic drugs
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome: <br/ ><br>1.Co-enzyme Q10 levels in patients on statin therapyTimepoint: Primary Outcome: <br/ ><br>1.Co-enzyme Q10 levels in patients on statin therapy
- Secondary Outcome Measures
Name Time Method 1.Comparison of serum CoQ10, serum HMG CoA reductase and serum CK-MM levels in patients having statin induced muscular adverse effects with those not having adverse effects.Timepoint: 1;2.Correlation of serum HMG CoA reductase levels with serum CoQ10 levels in patients having muscular adverse effects.Timepoint: 1;3.Comparison and correlation of serum CoQ10 and serum HMG CoA reductase levels in patients having statin induced neurological adverse effects with those not having adverse effects.Timepoint: 1