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Clinical Trials/CTRI/2021/07/034572
CTRI/2021/07/034572Not yet recruitingPhase 2/3

Open Labelled Clinical study to Evaluate the Effect of Draksha (Vitis Vinifera Lin) Panak in Dyslipidaemia.

Sane Guruji Arogya Kendra1 site in 1 country45 target enrollmentStarted: May 7, 2021Last updated:
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Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
45
Locations
1
Primary Endpoint
A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is open labelled Randomized comparative clinical trial to evaluate the effect of Draksha (vitis vinifera Lin.) Panak for 60 days with Pathya ahara in patients with Dyslipidaemia. The Primary outcome will be on Blood Lipid levels in patients with Dyslipidaemia.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Patient of age group 20 to 50 years,irrespective of their gender, religion.
  • •2.Patients with abnormal Sr. lipid levels are singly, or in the cluster of two or all three.
  • •3.Irrespective of taking lipid lowering drug therapy.
  • •4.Irrespective of family hidtory of Atherosclerotic Cardiovascular Disease (ASCVD), Dyslipidaemia.
  • •5.Patient irrespective of known case of HTN.

Exclusion Criteria

  • •1.Patient with Mrudu koshta.
  • •2.Patient known case of Diabetes Mellitus.
  • •3.pregnant Woman.
  • •4.Patient with known case of Atherosclerotic Cardiovascular Disease/ ischemic heart disease.
  • •5.Patient with operated for heart blockages like PTCA or Bypass surgery.
  • •Patient with known congenital heart disease.

Outcomes

Primary Outcomes

A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment.

Time Frame: The drug will be given for 60 days. Patient will be assessed on 25th day, 30th day, 45th day and 60th day of the treatment.Total duration of the study will be 2 months

Secondary Outcomes

  • A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment. therefore secondary outcome will relief in sign and symptoms of dyslipidaemia(The drug will be given for 60 days. Patient will be assessed on 25th day, 30th day, 45th day and 60th day of the treatment.Total duration of the study will be 2 months)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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