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Completed

NCT Number: NCT04120259

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziauddin University

Karachi, Sindh, 7500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Oral Tablet

Drug

A biguanide drug used as a first line therapy for Diabetes MellitusType 2

Vinegar

Dietary Supplement

A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.

Primary outcomes

  1. BMI (Anthropometric Measurement)

    Time frame: 12 weeks

    Body Mass Index: A measure of obesity calculated as weight in kilograms divided by height in meters square

  2. Measurement of Hemoglobin A1c

    Time frame: 12 weeks

    A blood test for Glycated Hemoglobin that represents a 2-3 month glycemic control

  3. Measurement of Fasting Blood Sugar

    Time frame: 12 weeks

    A blood test that involves the measurement of plasma glucose after 8 to 12 hours of fasting

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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