Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics
1 other identifier
interventional
126
1 country
1
Brief Summary
'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Apr 2019
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2019
CompletedFirst Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedOctober 21, 2019
October 1, 2019
4 months
October 7, 2019
October 17, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Group 1
ACTIVE COMPARATORIntervention: Metformin Tablet oral 750 mg OD
Group 2
EXPERIMENTALIntervention: Metformin 750 mg oral plus 2 tablespoons of apple cider vinegar OD
Interventions
A biguanide drug used as a first line therapy for Diabetes MellitusType 2
A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziauddin University
Karachi, Sindh, 7500, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Momina Abid, MBBS,M Phil (ongoing)
Ziauddin University
- PRINCIPAL INVESTIGATOR
Dr Zahida Memon, MBBS,M Phil,PhD
Ziauddin University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Momina Abid
Study Record Dates
First Submitted
October 7, 2019
First Posted
October 9, 2019
Study Start
April 22, 2019
Primary Completion
August 26, 2019
Study Completion
August 26, 2019
Last Updated
October 21, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share