Home » Trials » SLCTR/2013/035
Hypoglycaemic activity of natural plants and callus cultures Munronia pinnata on type 2 diabetic subjects: a randomized controlled trial.
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SLCTR Registration Number
SLCTR/2013/035
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Hypoglycaemic activity of natural plants and callus cultures Munronia pinnata on type 2 diabetic subjects: a randomized controlled trial.
Public Title of Trial
Oral hypoglycaemic activity of Binkohomba (Munronia pinnata) on type 2 diabetic subjects
Disease or Health Condition(s) Studied
Type 2 diabetes mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Hypoglycaemic activity of M. pinnata on diabetic subjects
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
UGC/ICD/045 (UGC Research Grant Number)
What is the research question being addressed?
What is the efficacy and safety of M. pinnata (Binkohomba) on blood glucose levels in patients with type 2 diabetes on diet control?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 1
Intervention(s) planned
The study will be conducted at the OPD clinic of the Dravyaguna Vignana Department of the National Hospital of Ayurveda, Borella.
Consenting participants meeting inclusion/exclusion criteria will be randomized into three groups (n=30 in each) using computer generated random numbers.
Group 1 will receive the aqueous extract of the calli of M. pinnata (60g/kg, 120ml twice a day) for 3 months, in addition to diet control.
Group 11 will be receive the aqueous extract of the natural plants of M. pinnata (60g/kg, 120mL per twice a day) for three months in addition to diet control(recommended dose in Ayurveda (Sharma,1996 ).
Group 111 will be on diet control only.
All patients will receive detailed advice on diet as indicated in the national guidelines for the management of Type II diabetics (SLMA, 2000)
Total duration of the intervention is three months
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Fasting blood glucose |
[ Prior to administration of aqueous extracts, monthly and at the end of three months. ] |
|
2.
Oral glucose tolerance test (OGTT) |
[ Prior to administration of aqueous extracts, monthly and at the end of three months. ] |
|
3.
HbA1c |
[ At baseline and at the end of 3 months ] |
Secondary outcome(s)
|
1.
Changes in liver enzymes (AST and ALT) and serum creatinine |
[ At base line and at the end of three months ] |
Target number/sample size
90 (30 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-11-19
Anticipated end date
2014-01-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Grants Commission, Sri Lanka (PhD Research Grant No: UGC/ICD/045)
Regulatory approvals
Status
Approved
Date of Approval
2012-01-26
Approval number
592/11
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. Sugandhika Suresh
Senior Lecturer
Department of Biochemistry,
Faculty of Medical Sciences,
University of Sri Jayewardenepura
0112-802164
0777314565
malalavidhane@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
