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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120259
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: August 26, 2019

Study information

• Verified date: October 2019
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin Oral Tablet
A biguanide drug used as a first line therapy for Diabetes MellitusType 2

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

Locations

Country	Name	City	State
Pakistan	Ziauddin University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

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