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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02290925 |
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Date of registration:
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07/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
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Scientific title:
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The Effect of a Biscuit Containing the Extract of Salacia Reticulata on Glycaemia in Patients With Type 2 Diabetes Mellitus Randomized Triple Blind Placebo Controlled Two Period Two Sequence Crossover Clinical Trial |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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133 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02290925 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Nadeesha Wickramasinghe, BSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Type 2 diabetes for minimum period of 6 months
2. Aged between 30 and 65 years
3. 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 Criteria:
1. Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour
2. Severe valvular heart disease or heart failure.
3. Those on Insulin therapy
4. Severe liver disease (AST > 10 X times the upper limit)
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Dietary Supplement: Placebo Biscuit
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Drug: Kothala Himbutu Biscuit
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Primary Outcome(s)
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Glycosylated Haemoglobin
[Time Frame: After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)]
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Secondary Outcome(s)
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Renal Adverse Effects -1
[Time Frame: baseline, after 3 months and after 7 months]
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Liver Adverse Effects
[Time Frame: Baseline, after 3 months, and after 7 months]
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Renal Adverse Effects - 2
[Time Frame: Baseline, after 3 months, and after 7 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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