Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics

Study Overview
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Brief Summary
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'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients

Detailed Description
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Diabetes Mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well. Metformin has been considered first line for the treatment of Type 2 Diabetes, however presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a few. Vinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. This study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.

Official Title
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Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics:A Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Metformin Oral Tablet
* Dietary Supplement: Vinegar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently diagnosed Type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent Patients with Hemoglobin A1c in the range of 6.5 to 7.5% Exclusion Criteria: All newly diagnosed Diabetic Patients requiring a dosage other than 750 mg per day Patients on Insulin Therapy or any drugs for diabetes other than Metformin Pregnant and Lactating women Patients with food allergies to either apple or any source of vinegar Patients unable to communicate efficiently\mentally challenged Type 2 Diabetic patients with any of the complications of long standing uncontrolled diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Intervention: Metformin Tablet oral 750 mg OD | Drug: Metformin Oral Tablet<br>* A biguanide drug used as a first line therapy for Diabetes MellitusType 2<br>|
| Experimental: Group 2<br>Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD | Drug: Metformin Oral Tablet<br>* A biguanide drug used as a first line therapy for Diabetes MellitusType 2<br>Dietary Supplement: Vinegar<br>* A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (Anthropometric Measurement) | Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square | 12 weeks | 
| Measurement of Hemoglobin A1c | A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control | 12 weeks | 
| Measurement of Fasting Blood Sugar | A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting | 12 weeks |