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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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19 February 2015 |
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Main ID: |
NCT00940251 |
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Date of registration:
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14/07/2009 |
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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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Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs
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Scientific title:
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Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00940251 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Secondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c
levels > 8.5% even after supplementation of maximal dose of a combination of a
sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin
1500 mg/day.
Exclusion Criteria:
Patients with ketosis, diabetes related complications, hepatic or renal disease,
pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune
deficiency
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
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Intervention(s)
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Drug: Mersina
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Primary Outcome(s)
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antidiabetic activity
[Time Frame: 3 months]
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Secondary Outcome(s)
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Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile
[Time Frame: 3 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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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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