Home » Trials » SLCTR/2013/015
A controlled cross over trial to evaluate the hypoglycaemic effect of water extract of dried flowers of Aegle marmelos (Bael fruit) in diabetic patients
-
SLCTR Registration Number
SLCTR/2013/015
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A controlled cross over trial to evaluate the hypoglycaemic effect of water extract of dried flowers of Aegle marmelos (Bael fruit) in diabetic patients
Public Title of Trial
Evaluation of the oral hypoglycaemic activity of water extract of dried flowers of Aegle marmelos (Bael fruit) in diabetic patients
Disease or Health Condition(s) Studied
Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Oral hypoglycaemic activity of water extract of dried flowers of Aegle marmelos in diabetic patients.
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
681/12 (Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura)
What is the research question being addressed?
Does the water extract of dried flowers of Aegle marmelos reduce plasma glucose levels in diabetic patients after continuous consumption of the water extract for 2 weeks?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Crossover
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The water extract will be prepared daily by boiling 25 g of dried flowers of A. marmelos in 500 ml water until reduced to 50 ml. 50 ml will be consumed by a patient daily.
Diabetic patients on diet control will be selected by an open advertisement.
Following a 8-10 hrs fast , fasting blood glucose levels will be assessed. Then a standard glucose tolerance test (75 g glucose in 300 ml water) will be performed with the subjects receiving distilled water (50 ml) 30 min prior to glucose loading.
For the single dose experiment, the same subjects will receive the water extract of dried flowers of Aegle marmelos (50ml) after 8-10 hrs fast. Then a standard glucose tolerance test (75 g glucose in 300 ml water) will be performed.
For the multiple dose experiment, the same subjects will receive the water extract of dried flowers of Aegle marmelos (50ml) every morning for two weeks continuously. At the end of two weeks, following a 8-10 hrs fast, fasting blood glucose levels will be assessed. Then glucose tolerance test will be repeated with the subjects receiving the extract 30 minutes prior to the glucose loading
Inclusion criteria
1.Type 2 diabetic patients 2.Age 30 – 70 years 3.On diet control only
Exclusion criteria
Primary outcome(s)
|
1.
Change in plasma glucose level 1. Fasting plasma glucose 2. Oral glucose tolerance test |
[ On control date, following the first dose and after 2 weeks ] |
Secondary outcome(s)
|
1.
Changes in 1. Liver enzymes 2. Heamoglobin (Hb) 3. Serum creatinine |
[ At baseline and at the end of 4 weeks ] |
Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2013-04-01
Anticipated end date
2013-05-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
WCUP/PhD/03/2012 : University of Sri Jayewardenepura.
Regulatory approvals
Status
Approved
Date of Approval
2012-10-25
Approval number
681/12
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
Dr. (Mrs.) T. Sugandhika Suresh
Senior Lecturer
Department of Biochemistry,
Faculty of Medical Sciences,
University of Sri Jayewrdenepura, Gangodawilla, Nugegoda
0112801480
0777314565
malalavidhane@yahoo.com
Contact Person for Public Queries
K. D. K. Peshala Kumari
Reserch Assitant
Department of Biochemistry, Faculty of Medical Sciences, University of Sri Jayewrdenepura, Gangodawilla, Nugegoda
0112801480
0718221738
kripeshala@gmail.com
Primary study sponsor/organization
University of Sri Jayewrdenepura
Gandgodawilla, Nugegoda.
0112801604,0112802696
unisj@sjp.ac.lk
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
