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Clinical Trials/CTRI/2024/09/074424
CTRI/2024/09/074424Not yet recruitingPhase 2

An Open Labelled Randomised Controlled clinical study to evaluate the safety and efficacy of Qurs-e-Luk in cases of Fart-e-Tadassum fid-dam (Hyperlipidemia)

PG Dept. of Moalijat1 site in 1 country40 target enrollmentStarted: October 5, 2024Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To reduce the abnormal elevated range of Triglycerides,serum LDL and VLDL cholesterol, serum total Cholesterol.and maintain normal HDL Cholesterol up to 50mg/dl.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Hyperlipidemia is one of the most important risk factor of Heart attack and stroke, it affects about 75-85% in the control population of comparable age. It impacts on patient health & social life which effect very badly.

My aim to evaluate the therapeutic efficacy of formulated Unani drug and relief the nature of the disease.

Management of Hyperlipidemia with sample size of 40 and 2 months treatment with some inclusion and exclusion criteria ( mentioned in part 6).

The study has been planned.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Diagnosed cases of primary hyperlipidemia is selected for this clinical trial .
  • •2.Patient with Serum Triglycerides (TG) more than 200-499 mg/dl , and Serum LDL Cholestrol more than 160-189 mg/dl, Serum Total Cholestrol more than 240 mg/dl,and VLDL less than30mg/dl.
  • •HDL Cholestrol up to 50 mg/dl included in this study.

Exclusion Criteria

  • •1.Pregnant & Lactating women 2.Severe active coronary artery disease & Ischemic Heart disease.
  • •Uncontrolled DM 4.Alcoholism 5.Mentally retarded patients.
  • •6.Patients with severe systemic disease & organ failure.

Outcomes

Primary Outcomes

To reduce the abnormal elevated range of Triglycerides,serum LDL and VLDL cholesterol, serum total Cholesterol.and maintain normal HDL Cholesterol up to 50mg/dl.

Time Frame: once in 2 weeks

Secondary Outcomes

  • To maintain body weight, and reduce the risk factor of cardiovascular diseases.(once in 2 weeks)

Investigators

Sponsor
PG Dept. of Moalijat
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Fareeha Kausar

Govt. Nizamia Tibbi College and General hospital

Study Sites (1)

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