Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics

NCT ID: NCT05759442

Last Updated: 2023-08-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to compare efficacy and safety of metformin versus apple cider vinegar in prediabetics . The main question\[s\] it aims to answer are:

* Efficacy of metformin versus apple cider vinegar in prediabetics
* Safety of metformin versus apple cider vinegar in prediabetics

Researchers will compare group of prediabetics taking metformin with group of prediabetics taking apple cider vinegar to see if there is difference in safety and efficacy..

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PreDiabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open label, prospective, clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metformin

Tablet Metformin HCl 500 mg per oral twice daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride (HCL)

Intervention Type DRUG

Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics

Apple cider vinegar

Apple Cider Vinegar 15ml per day diluted in 200 ml of water for 12 weeks

Group Type ACTIVE_COMPARATOR

Apple cider vinegar

Intervention Type DIETARY_SUPPLEMENT

Apple cider vinegar aimed at improving glycemic indices in Prediabetics

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metformin Hydrochloride (HCL)

Tab Metformin HCL 500mg twice per day aimed at improving glycemic indices in Prediabetics

Intervention Type DRUG

Apple cider vinegar

Apple cider vinegar aimed at improving glycemic indices in Prediabetics

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males and Female
* 17-40 years age
* Body Mass index (BMI) overweight and obese
* FBS (100-125 mg/dl)
* HBA1c 5.7% to 6.4%

Exclusion Criteria

* Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
* Known allergy or intolerance to metformin or apple cider vinegar
Minimum Eligible Age

17 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bahria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Shizma Junejo

Senior Lecturer Pharmacology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr.Shizma Junejo, MBBS,MSc

Role: PRINCIPAL_INVESTIGATOR

Bahria University Health Sciences Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diabetologist Clinics (02)

Karachi, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ERC 123/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.