Status:
COMPLETED
The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
Lead Sponsor:
Rajarata University, Sri Lanka
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-65 years
Phase:
PHASE3
Brief Summary
The investigators intend to conduct a triple blind randomized clinical trial to investigate the effect of a biscuit containing herbal extract, available in the market on the fasting blood sugar contro...
Detailed Description
The effect of a biscuit containing the extract of Salacia reticulata (Kothala Himbutu) on the reduction of blood glucose levels in patients with Type 2 Diabetes Mellitus. A single center randomized tr...
Eligibility Criteria
Inclusion
- Type 2 diabetes for minimum period of 6 months
- Aged between 30 and 65 years
- Stable glycaemic control over the preceding 2-3 months. They will be initially selected from a range of HBA1C varying from 6.5 - 14 and the individual subject should not have a variation of \>20% between the previous HBA1C and the HBA1C done at the commencement of the study
Exclusion
- Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour
- Severe valvular heart disease or heart failure.
- Those on Insulin therapy
- Severe liver disease (AST \> 10 X times the upper limit)
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT02290925
Start Date
May 1 2014
End Date
April 1 2017
Last Update
May 14 2019
Active Locations (1)
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1
Teaching Hospital Anuradhapura
Anuradhapura, North Central Province, Sri Lanka, 50000