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

NCT ID: NCT04120259

Last Updated: 2019-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2019-08-26

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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Intervention: Metformin Tablet oral 750 mg OD

Group Type ACTIVE_COMPARATOR

Metformin Oral Tablet

Intervention Type DRUG

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

Group 2

Intervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD

Group Type EXPERIMENTAL

Metformin Oral Tablet

Intervention Type DRUG

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

Vinegar

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Metformin Oral Tablet

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

Intervention Type DRUG

Vinegar

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziauddin University

OTHER

Sponsor Role lead

Responsible Party

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Dr Momina Abid

Dr Momina Abid

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Momina Abid, MBBS,M Phil (ongoing)

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University

Dr Zahida Memon, MBBS,M Phil,PhD

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University

Locations

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Ziauddin University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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