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A controlled trial to compare the diuretic action of frusemide with the Ayurvedic diuretic medicinal preparations Gokshura guggulu, Chandraprabhavatin and Vajrakshara -

SLCTR Registration Number

SLCTR/2007/010


Date of Registration

21 Sep 2007

The date of last modification

Nov 21, 2017


Trial Status



Application Summary


Scientific Title of Trial

A controlled trial to compare the diuretic action of frusemide with the Ayurvedic diuretic medicinal preparations Gokshura guggulu, Chandraprabhavatin and Vajrakshara


Public Title of Trial

Comparison of diuretic actions of frusemide with Ayurvedic diuretics


Disease or Health Condition(s) Studied

Patients requiring diuretic therapy


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

ERC/07-018 (Ethics Review Committee of the Sri Lanka Medical Association)


Trial Details


What is the research question being addressed?

Are Ayurvedic diuretic medicines safe and effective?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Active


Assignment

Parallel


Purpose


Phase


Intervention(s) planned

Giving frusemide 40 mg orally and one of the three Ayurvedic preparations and assessing diuretic action by measuring urine flow rate, K+, Na+ and osmolar clearance


Inclusion criteria

Patients requiring diuretic therapy, but not seriously ill, giving voluntary informed consent


Exclusion criteria

Patients seriously ill



Primary outcome(s)

  1. Effective diuresis

    []

Secondary outcome(s)

  1. Adverse effects, patient preference

    []

Target number/sample size

100 patients (approx)


Countries of recruitment

Sri Lanka


Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion


Recruitment status

Complete


Funding source

National Science Foundation, Sri Lanka



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Colvin Goonaratna
Professor
Faculty of Medicine Kynsey Road Colombo 8
4612643
0773-488289
4612643
colvin_cg@yahoo.com

Contact Person for Public Queries

Colvin Goonaratna
Professor
Faculty of Medicine Kynsey Road Colombo 8
4612643
0773-488289
4612643
colvin_cg@yahoo.com


Primary study sponsor/organization

Faculty of Medicine, Colombo

Kynsey Road Colombo 8
4612643
4612643

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results