Home » Trials » SLCTR/2012/011
Influence of long term ingestion of Scoparia dulcis (Wal kottamalli) porridge on glycaemic and lipid parameters
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SLCTR Registration Number
SLCTR/2012/011
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Influence of long term ingestion of Scoparia dulcis (Wal kottamalli) porridge on glycaemic and lipid parameters
Public Title of Trial
Influence of long term ingestion of Scoparia dulcis (Sinhala: Walkottamalli) porridge on glycaemic and lipid parameters
Disease or Health Condition(s) Studied
Diabetes mellitus type II
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
632/12/01 (Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayawardenepura)
What is the research question being addressed?
Does the long term consumption of Scoparia dulcis (Wal koththamalli) green leafy porridge have any effect on diabetic parameters in patients with type II diabetes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Crossover
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Does the long term consumption of Scoparia dulcis (Wal koththamalli) green leafy porridge have any effect on diabetic parameters in patients with type II diabetes?
Inclusion criteria
•Patients with Type II diabetes •35-65 years • mild to moderate diabetes (FBG 126 – 200 mg/dL) • not currently consuming Scoparia dulcis extract/ porridge • ability to speak Sinhala or English
Exclusion criteria
• Type I diabetes • Macro vascular complications (stroke or myocardial infarction or both at least once in their life, recommended bypass surgeries (CABG), non-healing wounds, gangrene or amputated limbs/ toes; •Micro vascular complications (confirmed diabetic retinopathy confirmed diabetic nephropathy, elevated arterial blood pressure, confirmed kidney failure, confirmed diabetic neuropathy, • patients who refuse consent • current users of Scoparia dulcis extract/ porridge • patients who speak only Tamil
Primary outcome(s)
|
1.
liver profile, serum creatinine, lipid profile, serum ferritin, serum cortisol, HbA1c, fasting blood glucose |
[ At baseline and monthly for 3 months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
70
Countries of recruitment
Sri Lanka
Anticipated start date
2012-11-23
Anticipated end date
2013-03-15
Date of first enrollment
2012-12-15
Date of study completion
Recruitment status
Recruiting
Funding source
University grant of Sri Jayewardenepura, World Class University Project grant
Regulatory approvals
Status
Approved
Date of Approval
2012-08-30
Approval number
632/12
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Sagarika Ekanayake
Professor in Biochemistry
Dept. of Biochemistry, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda
011-2803578, 011-2801480
0716875891
sagarikae@hotmail.com
Contact Person for Public Queries
Prof. Sagarika Ekanayake
Professor in Biochemistry
Dept. of Biochemistry, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda
011-2803578, 011-2801480
0716875891
sagarikae@hotmail.com
Primary study sponsor/organization
Dept. of Biochemistry
Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda
011-2803578 011-2801480
biochemistry.fms@yahoo.com
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
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
