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The aim of the study is to get insight into control of glycemic variability with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.
The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyherbal | Active Comparator | Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea. |
|
| Placebo | Placebo Comparator | Placebo will contain an inert substance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal capsule coccinia, bougainvillea, catharanthus | Drug | A unique combination of 3 herbs that lower blood sugars |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean amplitude glycemic excursion | To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean estimated glycated hemoglobin | Mean estimated glycated hemoglobin difference between test and placebo control group | 14 days |
| Number of hypoglycemia episodes | Number of hypoglycemia episodes and duration of hypoglycemia in treatment group |
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Inclusion Criteria:
Adult males and non-pregnant females aged ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria
Exclusion Criteria:
Any one of the following
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| Name | Affiliation | Role |
|---|---|---|
| Alben Sigamani | Narayana Hrudayalaya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazumdar Shaw Medical Centre | Bangalore | Karnataka | 560099 | India |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo | Drug | Similar looking inactive powder |
|
| 14 days |