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Paraoxonase-1 activity and effect of statins

Assessment of modulation of activity of Paraoxonase-1 (PON-1) by statins in patients requiring statin therapy. - PSS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009376
Enrollment
140
Registered
2017-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E785- Hyperlipidemia, unspecified Health Condition 2: null- Statin Naive patients

Interventions

Intervention1: Atorvastatin: Atorvastatin 10/20mg given orally once a day for a duration of 3 months Control Intervention1: NIL: NIL

Sponsors

Research Society Seth GSMC and KEM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Statin naïve patients aged between 18 -75 years of either gender, eligible for statin treatment as per the physicianâ??s diagnosis 2. Patient willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients having contraindication to statin like a)Chronic renal failure or serum creatinine > 1.7 times the upper limit b)Unexplained serum CK > 3 times the upper limit of normal Active hepatitis or cholestasis or ALT > 2 times the upper limit of normal. c)Subjects taking one of the following medications and unable to maintain a stable dose at least four weeks prior to the screening visit and for the duration of the study: tamoxifen, raloxifene, estrogen and or progestins, thiazide diuretics, isotretinoin, Ã?-blockers, thyroid hormones, androgens, fiber supplements, protease inhibitors. 2. Patients requiring any other lipid lowering agent other than statins. 3. Patients having co-morbidities like any liver disease. 4. Pregnant and lactating women. 5. Inability to comply with the treatment and study protocol as per the investigatorâ??s judgment. 6. History of alcohol and substance abuse in last four weeks.

Design outcomes

Primary

MeasureTime frame
To study the effect of statins on PON-1 activity across different allelic variantsTimepoint: 4 months

Secondary

MeasureTime frame
To compare serum lipid levels before and after statin treatment and its correlation with PON-1 activityTimepoint: 4 months

Countries

India

Contacts

Public ContactCharuta Godbole

King Edward Memorial Hospital

urmilathatte@gmail.com9820198462

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026