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| Name | Class |
|---|---|
| Composite Interceptive Med-Science Laboratories Pvt Ltd | UNKNOWN |
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Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. It has become a major healthcare problem in India. High-quality, low-cost solutions adapted to the local context are critical to addressing the current crisis in the management of diabetes. Herbal tea consists of tulsi, guava and stevia, which has glucose lowering properties.The aim of this trial is to study the effect of a herbal tea in the glycemic response in the early type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Herbal tea | Active Comparator | One tea bag infusion three times a day each before breakfast, lunch and dinner. |
|
| Placebo Tea | Placebo Comparator | Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal Tea | Drug | All participants will be given the intervention in an infusion tea bag. Participant will be instructed to take one tea bag three times a day at before breakfast, lunch and dinner meals. At the time of randomization both active and placebo infusion bag will be provided.There will be one day of washout period after 2 days on treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) | Change from baseline in Fasting plasma glucose | 2 days and 5 days |
| Oral Glucose Tolerance Test (OGTT) | Change from baseline in OGTT | 2 days and 5 days |
| Number of Subject with adverse events | Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment. | 2 days and 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Flash Glucose Measurements | Change from baseline in mean amplitude glycemic excursions measured by flash glucose monitoring sensor | 2 days and 5 days |
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Inclusion Criteria:
Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria
Exclusion Criteria:
Any one of the following
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjaya Chauhan, Pharm.D | Contact | 09611252350 | drsanjayachauhan49@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| HD Ramachandra Prabhu, MBBS, MD | Health India Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health India Hospital | Bangalore | Karnataka | 560029 | India |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| ID | Term |
|---|---|
| D000069459 | Teas, Herbal |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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all the subjects will receive sequence of different study treatments.
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Double blinded study
|
| Placebo Tea | Drug | Similar looking inert placebo tea. |
|
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |