Home » Trials » SLCTR/2007/010
A controlled trial to compare the diuretic action of frusemide with the Ayurvedic diuretic medicinal preparations Gokshura guggulu, Chandraprabhavatin and Vajrakshara
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SLCTR Registration Number
SLCTR/2007/010
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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)
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
Basic science
Study Phase
Not Available
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
2007-10-01
Anticipated end date
2009-12-12
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
National Science Foundation, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2007-10-19
Approval number
ERC/07-018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
