Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Herbal Tea
* Drug: Placebo Tea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria Fasting Plasma Glucose ≥126 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND 2-h Post load Glucose ≥140 mg/dL during an OGTT. AND Glycosylated haemoglobin (A1C) ≥ 6.5 %. Exclusion Criteria: Any one of the following Patients on Insulin therapy. Patients on oral hypoglycemic agents other than metformin Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes. Women in child bearing age unable to practice any form of contraception Patients with diagnosis of Anaemia (Hemoglobin <11 g/dl in Female and <13 g/dl in Male) Impaired renal function; estimated glomerular function <60mls/min/1.73m2. Known history of any chronic illness taking regular pharmacological agents. Blood pressure fluctuations exceeding 20 mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 3 or more antihypertensive medications regularly in the last 6 weeks Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: all the subjects will receive sequence of different study treatments.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Herbal tea<br>One tea bag infusion three times a day each before breakfast, lunch and dinner. | Drug: Herbal Tea<br>* 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.<br>|
| Placebo Comparator: Placebo Tea<br>Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner. | Drug: Placebo Tea<br>* Similar looking inert placebo tea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herbal Tea, Diabetes