| Trial ID: | L3008 |
| Source ID: | NCT02866539
|
| Associated Drug: |
Polyherbal Capsule Coccinia, Bougainvillea, Catharanthus
|
| Title: |
Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Polyherbal capsule coccinia, bougainvillea, catharanthus|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of diabetes subjects achieving glycemic control, a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose \<180 mg/dl, 6 months|Number of pre-diabetes achieving euglycemic status, measured as A1c \< 5.7% and/or fasting plasma glucose \<100mg/dl/, 6 months |
|
| Sponsor/Collaborators: |
Sponsor: Composite Interceptive Med Science
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
122
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-12
|
| Completion Date: |
2018-01-15
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| Results First Posted: |
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| Last Update Posted: |
2018-04-11
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| Locations: |
Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital, Bangalore, Karnataka, 560099, India
|
| URL: |
https://clinicaltrials.gov/show/NCT02866539
|