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CompletedNCT02187757PrelipUpdated May 15, 2015

Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels

A Phase 3 interventional study of Study Dietary Supplement (Prelipid 500 mg capsules) and Placebo in Hyperlipidemia, sponsored by PreEmptive Meds, Pvt. Ltd. Completed at 8 sites in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-05-15.

Sponsored by PreEmptive Meds, Pvt. Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels

Read the detailed description

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels

02

Conditions studied

  • Hyperlipidemia

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Keywords

  • Dyslipidemia
  • High cholesterol
  • High LDL
  • Triglycerides
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 180 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

This is the only study on the registry with PreEmptive Meds, Pvt. Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories:

  1. Age ≥ 18 years to ≤ 65 years
  2. LDL cholesterol levels >120mg/dl
  3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures -

Exclusion criteria

Exclusion Criteria:

  1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.
  2. Cardiac status New York Heart Association class III-IV
  3. Uncotrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic
  4. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
  5. Clinically significant peripheral edema
  6. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
  7. Participants on steroid
  8. Pregnancy or lactating women
  9. Known hypersensitivity to any of the study drugs
  10. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
  11. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
  12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
  13. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
  14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study

  15. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    PreLipid

    Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification.

    Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)

  • Placebo comparator
    Placebo 600 mg capsules

    Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementStudy Dietary Supplement (Prelipid 500 mg capsules)

    Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.

    Also known as: PreLipid, Natural Cholesterol Supplement, Predisease

  • Dietary supplementPlacebo

    Also known as: Placebo 600 mg capsules

06

What researchers measure

Primary outcomes

  1. Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels

    Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days

    Time frame: Day 1 (Baseline) to Day 90 (End of Study)

  2. Safety of Dietary Supplement PreLipid 600 mg twice-daily

    Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)

    Time frame: Day 1(Baseline) to Day 90 (End of Study)

Secondary outcomes

  1. Changes in Glycemic Status

    To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.

    Time frame: Day 1 (Baseline) to Day 90 (End of Study)

Other outcomes

  1. Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function

    Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to End of Study (Day 90); Serum Creatinine from baseline (Day 1) to End of Study (Day 90)

    Time frame: Baseline (Day 1) to End of Study (Day 90)

07

Study locations

8 sites
  • Division of Clinical & Preventive Cardiology, Heart Institute
    Gurgaon, Delhi 122001, India
  • Life Care Institute of Medical Science & Research
    Ahmedabad, Gujarat 380014, India
  • Bhatia Hospital Medical Research Society
    Mumbai, Maharashtra 400007, India
  • Dr. Vikas Govind Pai Clinical Research Foundation
    Pune, Maharashtra 411005, India
  • Fortis Escorts Hospital
    Jaipur, Rajasthan 302017, India
  • Pace Clinical Research Center
    Bangalore, Tamil Nadu 560043, India
  • Singvi Health Centre
    Chennai, Tamil Nadu 600079, India
  • Rangammal Hospital
    Tiruvannamalai, Tamil Nadu 606003, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02187757
Lead sponsor
PreEmptive Meds, Pvt. Ltd
Collaborators
Abbott
Responsible party
Joe Fenn (Chairman, Department of Clinical & Preventive Cardiology, Medanta, The Medicity, India) — Principal investigator
First posted
Jul 11, 2014
Start date
Nov 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
May 15, 2015

Study contacts

Ravi Kasliwal, MD, DM, FIMSA
study chair · Medanta, The Medicity, India

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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